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CompletedNCT02944383INDIGO-1Updated Jun 25, 2020Results posted

A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia

A Phase 2 interventional study of Gemcabene and Placebo in Severe Hypertriglyceridemia and Mixed Dyslipidaemia, sponsored by NeuroBo Pharmaceuticals Inc.. Completed at 49 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-25.

Sponsored by NeuroBo Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)

02

Conditions studied

  • Severe Hypertriglyceridemia
  • Mixed Dyslipidaemia

Keywords

  • Hypertriglycerides
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 91 is close to the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

NeuroBo Pharmaceuticals Inc. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects who meet all of the following criteria will be eligible to participate in the study:

  1. Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedure;

  2. Male or female (neither pregnant or lactating) ≥18 years of age at time of consent;

    1. Women of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine dipstick on Study Day 1 prior to dosing in order to qualify for the study. Women who are surgically sterile or are clinically confirmed to be post-menopausal (i.e., documented amenorrhea for ≥ 1 year in the absence of other biological or physiological causes) are not considered to be of child-bearing potential;
    2. Women of child-bearing potential must agree to use acceptable methods of contraception throughout the duration of the study and for 30 days after the last dose of study drug. For this study, double-barrier contraception is required.
  3. Currently on a self-reported, stable, low-fat, low-cholesterol diet in combination with stable statins with or without ezetimibe (10 mg QD) for at least 12 weeks prior to the Screening Visit;
  4. Mean fasting TG value ≥ 500 mg/dL to \< 1500 mg/dL (with the higher value no more than 50% greater than the lower value) from the S1 and S2 Visits (or alternatively S2 and S3);
  5. Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;
  6. Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m²; and
  7. Subjects with Type 2 diabetes who take anti-diabetes pharmacologic therapy must be on a stable a regimen for at least 3 months, with no planned changes in medications for the study duration.

Exclusion criteria

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in the study:

  1. Known and previously documented homozygous genetic deficiencies (LPL, ApoC-II, ApoC-III, ApoA-V, GPIHBP1, or LMF1);
  2. History of pancreatitis within the last 6 months prior to screening (Visit S1);
  3. History of bariatric surgery; symptomatic gallstone disease, unless treated with cholecystectomy;
  4. Abnormal liver function test at the Pre-Screening Visit or any of the Screening Visits (aspartate aminotransferase or alanine aminotransferase > 2 × the upper limit of normal [ULN], total bilirubin > 1.5 × ULN, or alkaline phosphatase > 2 × ULN based on appropriate age and gender normal values). Subjects with bilirubin > 1.5 × ULN and history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
  5. Active liver disease (e.g., cirrhosis, alcoholic liver disease, hepatitis B [HBV], hepatitis C [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of human immunodeficiency virus (HIV), or acquired immune deficiency virus;
  6. Moderate to severe renal insufficiency defined as an estimated GFR \< 60 mL/min/1.73 m2 (calculated using The Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or at any of the Screening Visits;
  7. Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria), confirmed by reflexive urine protein:creatinine ratio testing;
  8. Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or > 1.5 × ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to the Screening Visit;
  9. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus HbA1c value ≥8.5% based on results from the Pre-Screening Visit or the Screening Visit), or any diabetic subject taking a thiazolidinedione (e.g., pioglitazone, rosiglitazone);
  10. New York Heart Association Class III or IV heart failure (see Appendix C);
  11. Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit (S1). Subjects with adequately treated stable angina, per Investigator assessment, may be included;
  12. Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Study Day 1 prior to dosing ECG (QTcF > 450 msec for men and >470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;
  13. Uncontrolled hypertension, defined as sitting systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, and confirmed by repeat measurement;
  14. Currently receiving cancer treatment(s) or, in the Investigator's opinion, at risk of relapse for recent cancer;
  15. Inadequate washout of a PCSK9 inhibitor (8 weeks prior to the Screening Visit S1), a fibrate lipid lowering agent (6 weeks prior to the Screening Visit S1), niacin > 200 mg/day, OMG-3, bile acid sequestrants or other lipid lowering therapies (4 weeks prior to the Screening Visit S1);
  16. Use of any excluded medications or supplements within 3 months prior to S1 (e.g., potent cytochrome P450 [CYP] 3A4 inhibitors, see Appendix D);
  17. Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid regulating agent;
  18. History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subject alcohol restrictions (see Section 5.6.3);
  19. Previously treated with gemcabene (i.e., CI-1027); participation in another clinical study of an investigational agent or device concurrently or within 1 month prior to the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit; or
  20. Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    Gemcabene 300 mg

    Participants received 300 mg Gemcabene orally, once daily for 12 weeks.

    Drug: Gemcabene

  • Experimental
    Gemcabene 600 mg

    Participants received 600 mg Gemcabene orally, once daily for 12 weeks.

    Drug: Gemcabene

  • Placebo comparator
    Placebo

    Participants received matching placebo orally, once daily for 12 weeks.

    Drug: Placebo

Interventions

  • DrugGemcabene

    Gemcabene tablets administered orally once daily, for 12 weeks.

  • DrugPlacebo

    Placebo tablets administered orally once daily, for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF).

    Time frame: Baseline, EOS (average of week 10 and 12)

Secondary outcomes

  1. Percent Change From Baseline in Fasting Serum TG

    Time frame: Baseline, Weeks 2, 6, 10 and 12

  2. Change From Baseline in Fasting Serum TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  3. Percent Change From Baseline in TC

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  4. Change From Baseline in TC

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  5. Percent Change From Baseline in Non-HDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  6. Change From Baseline in Non-HDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  7. Percent Change From Baseline in VLDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  8. Change From Baseline in VLDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  9. Percent Change From Baseline in HDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  10. Change From Baseline in HDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

  11. Percent Change From Baseline in Apolipoprotein B

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  12. Change From Baseline in Apolipoprotein B

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  13. Percent Change From Baseline in Apolipoprotein A-I

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  14. Change From Baseline in Apolipoprotein A-I

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  15. Percent Change From Baseline in Apolipoprotein A-II

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  16. Change From Baseline in Apolipoprotein A-II

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  17. Percent Change From Baseline in Apolipoprotein C-II

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  18. Change From Baseline in Apolipoprotein C-II

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  19. Percent Change From Baseline in Apolipoprotein C-III

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  20. Change From Baseline in Apolipoprotein C-III

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  21. Percent Change From Baseline in Apolipoprotein E

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  22. Change From Baseline in Apolipoprotein E

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  23. Percent Change From Baseline in LDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  24. Change From Baseline in LDL-C

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  25. Percent Change From Baseline in LDL-TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  26. Change From Baseline in LDL-TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  27. Percent Change From Baseline in VLDL-TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  28. Change From Baseline in VLDL-TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  29. Percent Change From Baseline in HDL-TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  30. Change From Baseline in HDL-TG

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  31. Percent Change From Baseline in Lipoprotein Size

    Percent change from baseline in Particle size for VLDL, HDL and LDL were reported.

    Time frame: Baseline, Week 12

  32. Change From Baseline in Lipoprotein Size

    Change from baseline in Particle size for VLDL, HDL and LDL were reported.

    Time frame: Baseline, Week 12

  33. Percent Change From Baseline in Lipoprotein Particle Number

    Percent change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.

    Time frame: Baseline, Week 12

  34. Change From Baseline in Lipoprotein Particle Number

    Change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.

    Time frame: Baseline, Week 12

  35. Percent Change From Baseline in HDL Particle Number

    Time frame: Baseline, Week 12

  36. Change From Baseline in HDL Particle Number

    Time frame: Baseline, Week 12

  37. Percent Change From Baseline in High-sensitivity C-reactive Protein

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  38. Change From Baseline in High-sensitivity C-reactive Protein

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  39. Percent Change From Baseline in Fibrinogen

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  40. Change From Baseline in Fibrinogen

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  41. Percent Change From Baseline in Serum Amyloid A

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  42. Change From Baseline in Serum Amyloid A

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  43. Percent Change From Baseline in Adiponectin

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)

  44. Change From Baseline in Adiponectin

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)

  45. Percent Change From Baseline in Angiopoietin 4

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)

  46. Change From Baseline in Angiopoietin 4

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)

  47. Percent Change From Baseline in Interleukin-6

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  48. Change From Baseline in Interleukin-6

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

  49. Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L)

    EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

    Time frame: Weeks 10, 12 and EOS (average of week 10 and 12)

07

Results

Posted Jun 25, 2020

Participant flow

Participant flow — Overall Study
MilestoneGemcabene 600 mgGemcabene 300 mgPlacebo
Started303031
Completed293030
Not completed101
Withdrew: Lost to follow-up001
Withdrew: Withdrawal by subject100

Outcome measures

PrimaryPercent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF).

Time frame:
Baseline, EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)-47.32 (-59.58 to -30.93)-32.95 (-48.53 to -12.21)-27.30 (-41.90 to 10.12)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0063 · Median difference (net): -19.02 · 95% CI -33.07 to -4.25Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2350 · Median difference (net): -7.63 · 95% CI -25.88 to 7.05Estimates generated from Hodges-Lehmann method.
SecondaryPercent Change From Baseline in Fasting Serum TG
Time frame:
Baseline, Weeks 2, 6, 10 and 12
Reported as:
Median · Percent Change
Percent Change From Baseline in Fasting Serum TG
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-27.46 (-49.03 to -14.03)-27.10 (-46.77 to 2.24)-27.07 (-37.53 to 11.01)
Week 6-38.63 (-50.24 to -18.99)-25.11 (-46.46 to -5.47)-22.18 (-41.48 to -5.17)
Week 10-49.90 (-58.32 to -25.53)-32.83 (-47.65 to -18.99)-18.75 (-46.07 to 11.55)
Week 12-41.88 (-57.53 to -25.04)-36.01 (-48.92 to -10.10)-37.30 (-48.35 to -5.46)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1663 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6195 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0436 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5000 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0007 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1161 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1830 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.8762 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
SecondaryChange From Baseline in Fasting Serum TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Fasting Serum TG
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-221.83 (-359.00 to -83.67)-161.00 (-306.67 to 11.67)-163.67 (-302.67 to 58.00)
Week 6-272.33 (-355.33 to -162.67)-173.83 (-301.33 to -27.67)-130.00 (-263.67 to -33.0)
Week 10-298.33 (-456.33 to -141.00)-173.50 (-390.67 to -105.67)-131.00 (-312.67 to 91.00)
Week 12-234.33 (-482.33 to -165.00)-230.67 (-308.33 to -59.67)-202.67 (-407.67 to -32.00)
EOS-288.42 (-411.83 to -156.33)-219.67 (-340.83 to -71.17)-154.00 (-380.33 to 49.83)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1780 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7615 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0162 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3710 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0010 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0988 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2594 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9099 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0219 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3494 (Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in TC

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in TC
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-12.67 (-24.84 to 2.33)-4.48 (-20.00 to 4.73)-2.67 (-14.74 to 7.38)
Week 6-17.00 (-26.25 to 0.85)-8.68 (-13.66 to 4.67)-6.12 (-13.43 to 5.31)
Week 10-17.23 (-30.86 to -6.50)-8.44 (-17.83 to 2.29)-2.42 (-12.56 to 10.20)
Week 12-10.25 (-30.94 to -1.81)-8.62 (-13.18 to 7.34)-6.93 (-18.18 to 14.97)
EOS-13.65 (-31.91 to -5.13)-7.28 (-19.92 to 6.49)-2.82 (-16.46 to 10.80)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0391 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2455 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0260 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5704 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0009 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0846 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1763 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5576 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0086 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -14.66 · 95% CI -24.68 to -4.39Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1516 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Mean difference (net): -5.06 · 95% CI -15.02 to 3.64Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in TC

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in TC
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-25.75 (-65.00 to 5.00)-10.25 (-51.50 to 8.00)-5.50 (-36.00 to 17.00)
Week 6-41.50 (-76.50 to 2.00)-18.75 (-32.50 to 7.00)-13.50 (-31.50 to 6.50)
Week 10-41.25 (-89.00 to -13.50)-16.00 (-49.50 to 3.00)-2.50 (-33.50 to 20.50)
Week 12-28.25 (-79.00 to -3.50)-19.75 (-53.50 to 14.00)-14.00 (-42.50 to 29.50)
EOS-35.50 (-90.50 to -13.50)-14.25 (-51.50 to 8.50)-3.00 (-36.50 to 25.00)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0386 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1206 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0364 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4312 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0010 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0407 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1433 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2866 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0056 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0789 (Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Non-HDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Non-HDL-C
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-13.92 (-29.92 to -0.78)-6.35 (-21.52 to 3.23)-3.29 (-15.62 to 8.90)
Week 6-22.57 (-32.16 to -0.77)-10.55 (-14.29 to 2.84)-7.77 (-16.28 to 4.23)
Week 10-22.18 (-35.66 to -7.92)-11.18 (-22.19 to 2.23)-7.66 (-17.18 to 13.36)
Week 12-13.31 (-36.34 to -3.37)-9.92 (-19.31 to 11.35)-10.56 (-22.62 to 19.21)
EOS-15.64 (-38.11 to -5.26)-12.01 (-21.88 to 7.10)-3.98 (-20.80 to 11.56)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0277 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2502 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0161 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6567 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0010 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1257 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1440 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7642 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0107 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -16.40 · 95% CI -28.31 to -4.51Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2466 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -5.32 · 95% CI -16.73 to 5.52Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Non-HDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Non-HDL-C
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-30.75 (-73.50 to -2.00)-12.25 (-52.50 to 5.50)-6.50 (-36.00 to 15.00)
Week 6-43.50 (-81.50 to -2.50)-19.75 (-34.50 to 5.00)-16.50 (-38.50 to 6.00)
Week 10-45.00 (-93.00 to -15.50)-23.00 (-52.00 to 4.00)-7.50 (-39.50 to 22.00)
Week 12-29.00 (-90.00 to -9.00)-22.25 (-54.50 to 15.00)-16.00 (-51.00 to 31.00)
EOS-36.50 (-93.00 to -14.50)-21.25 (-50.00 to 11.50)-7.00 (-42.50 to 21.50)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0211 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1304 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0318 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4607 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0012 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0592 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1170 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3138 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0090 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1317 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in VLDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in VLDL-C
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-46.19 (-57.52 to -21.18)-46.27 (-63.78 to -5.41)-29.59 (-48.36 to 18.87)
Week 6-36.41 (-50.00 to -18.75)-43.31 (-50.51 to -4.55)-33.50 (-53.68 to -2.57)
Week 10-32.71 (-60.00 to -14.41)-16.67 (-52.90 to 11.01)-7.85 (-41.03 to 28.93)
Week 12-31.34 (-51.74 to -6.92)-19.14 (-39.80 to 15.38)-31.69 (-44.21 to 20.57)
EOS-31.95 (-50.00 to -12.50)-15.95 (-50.51 to 15.38)-17.57 (-39.89 to 27.71)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2395 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6380 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.7468 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8483 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0008 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0938 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3201 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9010 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0156 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -19.31 · 95% CI -39.06 to -1.49Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3456 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -5.98 · 95% CI -28.51 to 17.26Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in VLDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in VLDL-C
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 2-47.00 (-74.00 to -18.50)-60 (-84.00 to -4.00)-29.00 (-59.00 to 10.00)
Week 6-37.50 (-57.00 to -12.00)-50.00 (-70.00 to -3.00)-31.50 (-67.50 to -1.50)
Week 10-25.50 (-73.00 to -17.00)-15.00 (-68.00 to 12.00)-7.00 (-48.00 to 20.00)
Week 12-26.00 (-68.00 to -10.00)-19.00 (-73.00 to 12.00)-24.00 (-62.00 to 21.00)
EOS-32.50 (-56.00 to -10.50)-13.00 (-71.50 to 12.00)-19.50 (-63.00 to 23.00)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3714 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4415 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.7902 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6999 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0015 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0796 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.4225 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7687 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0437 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2735 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in HDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in HDL-C
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 25.96 (-3.03 to 28.57)3.85 (-7.14 to 14.29)4.35 (-7.69 to 15.38)
Week 65.33 (-6.67 to 17.65)7.42 (-7.14 to 13.33)0.00 (-3.70 to 21.21)
Week 105.87 (-4.35 to 29.41)7.14 (-4.00 to 18.75)10.34 (0.00 to 22.22)
Week 1214.72 (-9.52 to 23.81)7.29 (-3.70 to 20.00)7.69 (-4.35 to 25.00)
EOS9.30 (-7.50 to 23.53)7.04 (-7.69 to 17.86)8.70 (-3.85 to 21.74)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1042 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6204 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.8659 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9658 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.8238 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4874 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9467 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7467 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9081 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -0.41 · 95% CI -10.77 to 10.75Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5480 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -2.38 · 95% CI -11.82 to 6.86Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in HDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in HDL-C
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 22.00 (-1.00 to 7.00)1.00 (-2.00 to 4.00)1 (-3.00 to 4.00)
Week 61.50 (-2.00 to 5.00)2.00 (-2.00 to 4.00)0.00 (-1.00 to 6.00)
Week 102.00 (-1.00 to 7.00)2.00 (-1.00 to 4.00)3.00 (0.00 to 5.00)
Week 124.00 (-3.00 to 8.00)2.00 (-1.00 to 5.00)2.00 (-1.00 to 8.00)
EOS3.00 (-2.00 to 6.00)2.00 (-2.00 to 4.00)2.00 (-1.00 to 5.00)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1485 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6008 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9409 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9292 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.8455 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5256 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9217 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7401 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9386 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6352 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Apolipoprotein B

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Apolipoprotein B
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-10.5 (-28.1 to 4.3)-2.7 (-9.2 to 5.6)0.0 (-5.1 to 8.9)
Week 12-4.7 (-26.1 to 6.6)0.5 (-8.6 to 16.2)4.8 (-6.4 to 13.0)
EOS-5.9 (-25.7 to 4.9)-1.9 (-8.7 to 11.4)2.8 (-5.0 to 7.6)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0165 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3075 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1069 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6101 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0351 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -12.04 · 95% CI -23.79 to -1.08Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3746 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -3.15 · 95% CI -9.86 to 4.25Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Apolipoprotein B

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Apolipoprotein B
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-10.0 (-37.0 to 4.0)-4.0 (-13.0 to 6.0)0.0 (-5.0 to 9.0)
Week 12-7.0 (-30.0 to 8.0)0.5 (-13.0 to 12.0)5.5 (-6.0 to 16.0)
EOS-8.5 (-34.5 to 5.5)-1.8 (-13.0 to 9.5)2.8 (-5.5 to 9.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0133 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2044 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0855 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5114 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0289 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2950 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Apolipoprotein A-I

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Apolipoprotein A-I
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-3.3 (-9.7 to 6.3)5.1 (-5.6 to 12.2)2.7 (-3.4 to 6.5)
Week 125.9 (-4.9 to 12.1)4.0 (-2.7 to 13.2)2.1 (-3.6 to 10.8)
EOS1.2 (-4.5 to 8.1)4.6 (-1.4 to 12.4)2.0 (-5.4 to 9.9)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1992 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9945 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.5139 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8085 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.7644 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -0.77 · 95% CI -6.31 to 4.85Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9499 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Mean difference (net): 1.33 · 95% CI -4.34 to 6.66Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Apolipoprotein A-I

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Apolipoprotein A-I
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 105.0 (-13 to 7)6.0 (-7.0 to 13.0)4.0 (-5.0 to 9.0)
Week 128.0 (-6.0 to 16.0)4.5 (-3.0 to 15.0)2.5 (-4.0 to 15.0)
EOS1.5 (-7.0 to 10.0)5.5 (-2.0 to 13.0)2.5 (-7.0 to 14.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1521 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8982 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.6228 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9622 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.6643 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9071 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Apolipoprotein A-II

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Apolipoprotein A-II
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-3.2 (-8.1 to 5.9)6.9 (-3.3 to 12.5)0.0 (-7.1 to 7.3)
Week 120.0 (-2.9 to 10.0)4.5 (0.0 to 15.2)0.0 (-6.9 to 7.5)
EOS0.0 (-5.4 to 5.6)5.3 (-3.1 to 12.1)0.0 (-5.6 to 8.1)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.5647 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1073 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3858 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0916 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9473 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.0 · 95% CI -5.56 to 5.26Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0911 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 4.54 · 95% CI -1.83 to 9.95Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Apolipoprotein A-II

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Apolipoprotein A-II
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-1.0 (-3.0 to 2.0)2.0 (-1.0 to 4.0)0.0 (-2.0 to 3.0)
Week 120.0 (-1.0 to 4.0)1.5 (0.0 to 5.0)0.0 (-2.0 to 3.0)
EOS0.0 (-1.5 to 2.0)1.8 (-1.0 to 4.0)0.0 (-2.0 to 2.5)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.4623 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1678 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.4390 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1290 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9627 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0911 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Apolipoprotein C-II

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Apolipoprotein C-II
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 100.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)
Week 120.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (-10.0 to 0.0)
EOS0.0 (-5.0 to 0.0)0.0 (0.0 to 0.0)0.0 (-5.6 to 0.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2882 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4474 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.7875 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0600 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9832 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.00 · 95% CI 0.00 to 0.00Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1352 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.00 · 95% CI 0.00 to 0.00Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Apolipoprotein C-II

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Apolipoprotein C-II
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 100.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)
Week 120.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (-1.0 to 0.0)
EOS0.0 (-0.5 to 0.0)0.0 (0.0 to 0.0)0.0 (-0.5 to 0.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · ranked ANCOVA · p = 0.2857 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4486 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.7640 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0560 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9954 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1298 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Apolipoprotein C-III

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Apolipoprotein C-III
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-21.1 (-40.0 to -4.7)-14.3 (-35.6 to 11.1)-3.6 (-33.2 to 16.5)
Week 12-17.6 (-35.5 to -5.6)-6.4 (-27.7 to 14.3)-10.7 (-37.5 to 0.0)
EOS-17.6 (-39.6 to -7.1)-11.3 (-31.5 to 8.3)-8.1 (-29.3 to 9.1)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0161 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1806 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2657 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5996 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0270 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -11.39 · 95% CI -28.81 to 2.08Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5263 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -0.92 · 95% CI -16.88 to 15.50Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Apolipoprotein C-III

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Apolipoprotein C-III
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-6.0 (-12.0 to -2.0)-4.0 (-9.0 to 1.0)-1.0 (-10.5 to 3.0)
Week 12-4.0 (-9.0 to -1.0)-2.0 (-6.0 to 2.0)-3.0 (-13.0 to 0.0)
EOS-5.5 (-12.0 to -2.0)-3.3 (-8.0 to 2.0)-2.0 (-9.5 to 2.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0345 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2709 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3255 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7391 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0808 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6509 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Apolipoprotein E

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Apolipoprotein E
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-36.3 (-46.4 to -26.4)-22.6 (-42.4 to 8.2)-9.2 (-39.0 to 14.3)
Week 12-27.5 (-43.5 to -1.6)-14.6 (-41.7 to 10.0)-25.7 (-43.4 to 14.7)
EOS-33.2 (-45.3 to -13.5)-16.7 (-43.1 to 10.6)-10.4 (-40.2 to 20.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0004 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0412 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1937 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4740 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0116 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate) · Median difference (net): -14.32 · 95% CI -34.13 to 3.89Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1109 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -3.66 · 95% CI -23.85 to 14.26Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Apolipoprotein E

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Apolipoprotein E
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-3.0 (-5.4 to -1.9)-1.8 (-4.2 to 0.5)-0.9 (-4.4 to 1.0)
Week 12-2.2 (-4.0 to -0.1)-1.4 (-4.1 to 0.7)-1.8 (-5.5 to 1.6)
EOS-2.9 (-4.9 to -1.0)-1.3 (-4.2 to 0.5)-0.9 (-4.9 to 1.5)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0002 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0161 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3043 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4639 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0210 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0992 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in LDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in LDL-C
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-13.64 (-27.03 to 26.32)4.39 (-14.00 to 29.03)0.00 (-7.92 to 32.14)
Week 12-7.94 (-26.39 to 22.97)5.20 (-13.04 to 26.67)25.43 (2.99 to 42.86)
EOS-13.36 (-25.79 to 19.66)5.26 (-12.68 to 27.94)14.73 (0.00 to 37.50)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1512 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8400 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0244 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1803 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0307 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -24.41 · 95% CI -42.73 to -9.94Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5326 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -8.73 · 95% CI -23.33 to 7.68Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in LDL-C

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in LDL-C
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-12.00 (-42.00 to 15.00)3.00 (-14.00 to 23.00)0.00 (-6.0 to 18.00)
Week 12-10.00 (-23.00 to 17)4.50 (-16.00 to 25.00)17.50 (2.00 to 29.00)
EOS-11.50 (-31.00 to 19.00)5.75 (-11.50 to 21.00)8.75 (0.00 to 20.50)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1705 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9193 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0224 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2387 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0600 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6878 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in LDL-TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in LDL-TG
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-17.1 (-35.6 to -4.2)-12.2 (-33.3 to 7.1)0.8 (-19.8 to 13.9)
Week 12-17.5 (-45.8 to 9.1)-7.2 (-28.6 to 31.0)-6.0 (-18.6 to 12.7)
EOS-20.0 (-37.5 to 4.4)-9.3 (-17.8 to 16.1)-6.8 (-16.7 to 13.6)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0298 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0196 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2219 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4078 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0605 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -15.34 · 95% CI -31.68 to 1.30Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1768 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -4.08 · 95% CI -19.91 to 7.32Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in LDL-TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in LDL-TG
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-11.0 (-21.0 to -1.0)-6.5 (-19.0 to 2.0)0.5 (-10.0 to 7.5)
Week 12-10.0 (-29.0 to 4.0)-4.0 (-11.0 to 10.0)-3.0 (-11.0 to 7.0)
EOS-12.5 (-25.0 to 2.0)-4.0 (-12.0 to 5.0)-3.3 (-8.5 to 8.5)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0084 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0047 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1574 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3235 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0367 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0948 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in VLDL-TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in VLDL-TG
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-39.7 (-60.6 to -21.2)-32.8 (-58.6 to 28.7)-11.0 (-53.9 to 19.5)
Week 12-34.8 (-59.0 to -15.3)-27.0 (-47.5 to 8.8)-37.3 (-56.4 to -6.9)
EOS-35.2 (-57.7 to -23.3)-30.8 (-52.8 to 38.4)-23.9 (-51.3 to 10.6)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0037 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1328 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.4364 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8129 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0347 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -15.29 · 95% CI -36.54 to 2.35Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3617 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -2.14 · 95% CI -25.78 to 23.62Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in VLDL-TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in VLDL-TG
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-170.0 (-493.0 to -86.0)-129.5 (-241.0 to 84.0)-77.0 (-274.0 to 67.0)
Week 12-139.0 (-351.0 to -83.0)-103.5 (-320.0 to 52.0)-193.5 (-524.0 to -28.0)
EOS-164.0 (-468.0 to -76.5)-116.5 (-373.0 to 71.5)-126.8 (-384.0 to 92.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0085 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2112 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.7301 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6283 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0919 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5497 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in HDL-TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in HDL-TG
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-27.5 (-51.6 to -11.8)-6.5 (-35.8 to 11.5)-6.1 (-26.7 to 19.2)
Week 12-23.9 (-54.1 to 3.0)-17.3 (-37.8 to -2.9)-11.1 (-31.3 to 21.7)
EOS-20.6 (-52.7 to 3.4)-11.2 (-39.0 to 3.8)-1.4 (-29.3 to 26.7)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0009 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0351 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1561 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0268 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0516 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -22.30 · 95% CI -42.96 to -1.67Estimates generated from Hodges-Lehmann method.
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0125 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -13.06 · 95% CI -32.83 to 4.88Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in HDL-TG

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in HDL-TG
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-8.0 (-25.0 to -3.0)-2.0 (-15.0 to 3.0)-2.0 (-11.0 to 6.0)
Week 12-8.0 (-25.0 to 1.0)-5.5 (-17.0 to -1.0)-4.0 (-12.0 to 5.0)
EOS-7.0 (-25.0 to 1.0)-3.5 (-16.0 to 1.0)-0.5 (-10.0 to 6.0)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0023 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0356 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2284 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0213 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0330 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0221 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Lipoprotein Size

Percent change from baseline in Particle size for VLDL, HDL and LDL were reported.

Time frame:
Baseline, Week 12
Reported as:
Median · Percent Change
Percent Change From Baseline in Lipoprotein Size
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
VLDL-7.83 (-16.46 to -0.31)-6.36 (-14.90 to 9.72)-5.17 (-16.55 to 3.34)
LDL0.00 (0.00 to 1.52)0.00 (0.00 to 0.95)0.51 (-0.51 to 1.03)
HDL0.000 (-2.299 to 2.273)0.000 (-2.353 to 2.353)0.000 (-2.151 to 1.205)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2632 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -2.67 · 95% CI -10.17 to 5.67Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5382 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 2.02 · 95% CI -6.77 to 9.71Estimates generated from Hodges-Lehmann method.
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1727 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.00 · 95% CI -0.51 to 1.01Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4567 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.00 · 95% CI -0.51 to 0.51Estimates generated from Hodges-Lehmann method.
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.6142 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.00 · 95% CI -1.21 to 1.47Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2409 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -0.02 · 95% CI -2.23 to 1.29Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Lipoprotein Size

Change from baseline in Particle size for VLDL, HDL and LDL were reported.

Time frame:
Baseline, Week 12
Reported as:
Median · nm
Change From Baseline in Lipoprotein Size
nmGemcabene 600 mgGemcabene 300 mgPlacebo
VLDL-5.10 (-10.60 to -0.20)-3.90 (-10.80 to 5.90)-3.10 (-12.20 to 2.30)
LDL0.00 (0.00 to 0.30)0.00 (0.00 to 0.20)0.10 (-0.10 to 0.20)
HDL0.000 (-0.200 to 0.200)0.000 (-0.200 to 0.200)0.000 (-0.200 to 0.100)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2721 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5669 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1686 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4308 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.5495 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2384 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Lipoprotein Particle Number

Percent change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.

Time frame:
Baseline, Week 12
Reported as:
Median · Percent Change
Percent Change From Baseline in Lipoprotein Particle Number
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
VLDL and Chylomicron Particles-15.82 (-22.82 to 7.60)-3.88 (-19.10 to 23.25)-4.03 (-14.33 to 26.67)
LDL Particles-9.83 (-32.15 to 7.53)-10.20 (-25.14 to 15.54)13.96 (-13.73 to 36.46)
IDL Particles-73.1 (-90.1 to 17.9)-2.2 (-83.2 to 36.3)16.7 (-67.5 to 217.6)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0781 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -13.99 · 95% CI -33.76 to 2.55Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9901 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -2.10 · 95% CI -19.36 to 19.01Estimates generated from Hodges-Lehmann method.
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0717 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -25.23 · 95% CI -43.62 to -5.10Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1548 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -16.09 · 95% CI -36.78 to 3.76Estimates generated from Hodges-Lehmann method.
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0428 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -47.16 · 95% CI -119.58 to -5.78Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1836 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -26.13 · 95% CI -121.44 to 19.48Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Lipoprotein Particle Number

Change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.

Time frame:
Baseline, Week 12
Reported as:
Median · nmol/L
Change From Baseline in Lipoprotein Particle Number
nmol/LGemcabene 600 mgGemcabene 300 mgPlacebo
VLDL and Chylomicron Particles-10.90 (-49.10 to 10.50)-6.40 (-32.30 to 24.50)-4.30 (-27.30 to 32.30)
IDL Particles-67.0 (-191.0 to 24.0)-14.0 (-72.0 to 31.0)1.0 (-96.0 to 86.0)
LDL Particles-103.00 (-525.00 to 88.00)-82.00 (-341.00 to 160.00)160.0 (-134.0 to 425)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1251 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9047 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0788 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1222 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0734 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4210 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in HDL Particle Number
Time frame:
Baseline, Week 12
Reported as:
Median · Percent Change
Percent Change From Baseline in HDL Particle Number
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Percent Change From Baseline in HDL Particle Number-0.578 (-11.111 to 13.889)0.304 (-5.079 to 12.253)0.000 (-5.296 to 8.696)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9672 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 0.43 · 95% CI -8.12 to 9.07Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.7993 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 1.58 · 95% CI -5.31 to 8.69Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in HDL Particle Number
Time frame:
Baseline, Week 12
Reported as:
Median · umol/L
Change From Baseline in HDL Particle Number
umol/LGemcabene 600 mgGemcabene 300 mgPlacebo
Change From Baseline in HDL Particle Number-0.200 (-4.100 to 3.400)0.100 (-1.600 to 3.800)0.000 (-1.600 to 2.300)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.8602 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8555 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in High-sensitivity C-reactive Protein

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in High-sensitivity C-reactive Protein
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-33.33 (-54.29 to 0.00)-26.67 (-44.90 to 15.56)-10.00 (-30.00 to 14.29)
Week 12-16.67 (-60.61 to 0.00)-25.48 (-57.89 to 5.56)10.99 (-28.57 to 42.86)
EOS-23.68 (-53.57 to 3.45)-16.94 (-55.26 to 17.11)-0.71 (-25.00 to 50.00)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0583 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2289 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0416 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0150 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0718 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -26.21 · 95% CI -54.29 to -1.26Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1248 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -18.68 · 95% CI -50.00 to 7.31Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in High-sensitivity C-reactive Protein

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in High-sensitivity C-reactive Protein
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-0.90 (-1.90 to 0.00)-0.40 (-1.50 to 0.20)-0.10 (-1.20 to 0.20)
Week 12-0.60 (-2.00 to 0.00)-0.50 (-1.50 to 0.10)0.10 (-0.40 to 1.20)
EOS-0.75 (-1.95 to 0.10)-0.28 (-1.50 to 0.40)-0.02 (-0.60 to 0.65)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.2397 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5399 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0409 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0073 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0976 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1899 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Fibrinogen

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Fibrinogen
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 101.2 (-11.0 to 13.5)-6.7 (-14.2 to 7.4)-3.5 (-10.2 to 8.8)
Week 12-1.8 (-15.0 to 5.4)-11.4 (-19.3 to 0.8)-3.4 (-11.6 to 4.6)
EOS-0.2 (-13.5 to 8.9)-8.4 (-15.1 to 0.8)-3.1 (-9.6 to 6.8)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1747 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4576 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1549 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2427 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1379 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 1.51 · 95% CI -6.26 to 8.73Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2490 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -6.02 · 95% CI -13.10 to 0.51Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Fibrinogen

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/dL
Change From Baseline in Fibrinogen
mg/dLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 105.0 (-50.0 to 54.0)-22.0 (-53.0 to 26.0)-15.0 (-38.0 to 37.0)
Week 12-7.0 (-63.0 to 23.0)-50.0 (-80.0 to 3.0)-12.0 (-46.0 to 17.0)
EOS-1.0 (-56.5 to 40.5)-35.0 (-71.0 to 3.0)-14.3 (-36.5 to 22.5)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1550 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.6604 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0952 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3006 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0642 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3185 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Serum Amyloid A

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Serum Amyloid A
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-33.3 (-45.8 to -16.2)-19.2 (-38.2 to -3.0)-12.5 (-31.5 to 0.0)
Week 12-36.7 (-58.7 to -15.4)-29.2 (-58.6 to 0.0)-7.2 (-20.6 to 17.3)
EOS-31.8 (-51.1 to -1.7)-19.6 (-52.9 to 8.9)-7.2 (-21.7 to 11.3)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0679 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4126 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0095 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0172 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0359 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -23.23 · 95% CI -41.54 to -3.64Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0812 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -16.06 · 95% CI -38.62 to 5.61Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Serum Amyloid A

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · mg/L
Change From Baseline in Serum Amyloid A
mg/LGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-1.5 (-2.5 to -0.7)-0.6 (-2.1 to -0.1)-0.4 (-1.6 to 0.0)
Week 12-2.1 (-3.3 to -0.6)-0.9 (-2.7 to 0.0)-0.3 (-1.3 to 0.9)
EOS-1.5 (-2.7 to -0.1)-0.8 (-2.7 to 0.5)-0.2 (-1.1 to 0.6)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1362 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6458 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0209 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.0822 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0504 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.1315 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Adiponectin

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Week 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Adiponectin
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 1212.9 (0.9 to 36.5)12.4 (-6.5 to 31.6)1.2 (-12.7 to 15.1)
EOS12.9 (0.9 to 36.5)12.4 (-6.5 to 31.6)1.2 (-12.7 to 15.1)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0843 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3587 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0843 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 12.99 · 95% CI -0.54 to 25.51Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3587 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 7.98 · 95% CI -3.70 to 21.39Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Adiponectin

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Week 12 and EOS (average of week 10 and 12)
Reported as:
Median · μg/mL
Change From Baseline in Adiponectin
μg/mLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 120.3 (0.0 to 0.9)0.3 (-0.2 to 0.8)0.0 (-0.7 to 0.6)
EOS0.3 (0.0 to 0.9)0.3 (-0.2 to 0.8)0.0 (-0.7 to 0.6)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0768 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4346 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.0768 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4346 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Angiopoietin 4

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Week 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Angiopoietin 4
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 128.5 (-5.1 to 21.7)-1.6 (-18.6 to 20.8)1.1 (-6.9 to 15.2)
EOS8.5 (-15.1 to 21.7)-1.6 (-18.6 to 20.8)1.1 (-6.9 to 15.2)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.5411 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2574 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.5411 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 3.11 · 95% CI -9.59 to 14.86Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.2574 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -7.31 · 95% CI -19.30 to 5.76Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Angiopoietin 4

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Week 12 and EOS (average of week 10 and 12)
Reported as:
Median · ng/mL
Change From Baseline in Angiopoietin 4
ng/mLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 1215.7 (-14.1 to 56.7)-2.0 (-36.8 to 48.5)2.8 (-9.1 to 22.5)
EOS15.7 (-14.1 to 56.7)-2.0 (-36.8 to 48.5)2.8 (-9.1 to 22.5)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3998 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3659 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3998 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3659 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercent Change From Baseline in Interleukin-6

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · Percent Change
Percent Change From Baseline in Interleukin-6
Percent ChangeGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-7.7 (-22.7 to 34.0)-10.2 (-37.3 to 14.7)-1.1 (-31.6 to 49.1)
Week 12-6.2 (-21.7 to 41.6)-7.5 (-34.4 to 21.3)-10.6 (-27.2 to 1.2)
EOS-5.3 (-17.7 to 30.7)-4.8 (-28.3 to 37.4)-4.2 (-27.2 to 35.5)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.8823 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.3788 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1091 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.6867 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.3156 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): 9.07 · 95% CI -12.22 to 36.34Estimates generated from Hodges-Lehmann method.
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.9734 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.) · Median difference (net): -0.30 · 95% CI -24.58 to 25.43Estimates generated from Hodges-Lehmann method.
SecondaryChange From Baseline in Interleukin-6

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Median · pg/mL
Change From Baseline in Interleukin-6
pg/mLGemcabene 600 mgGemcabene 300 mgPlacebo
Week 10-0.1 (-0.7 to 0.4)-0.1 (-0.8 to 0.3)-0.0 (-0.9 to 1.0)
Week 12-0.1 (-0.6 to 0.7)-0.2 (-0.7 to 0.3)-0.2 (-0.5 to 0.0)
EOS-0.1 (-0.6 to 0.6)-0.2 (-0.7 to 0.4)-0.1 (-0.6 to 0.4)
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.9772 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.5213 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.1582 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.4588 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 600 mg vs Placebo · Ranked ANCOVA · p = 0.4264 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
  • Gemcabene 300 mg vs Placebo · Ranked ANCOVA · p = 0.8107 (Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.)
SecondaryPercentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L)

EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.

Time frame:
Weeks 10, 12 and EOS (average of week 10 and 12)
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L)
Percentage of participantsGemcabene 600 mgGemcabene 300 mgPlacebo
Week 1073.363.341.9
Week 1263.353.341.9
EOS66.756.745.2
Statistical analysis
  • Gemcabene 600 mg vs Placebo · Regression, Logistic · p = 0.0093 (Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.) · Odds ratio (or): 5.38 · 95% CI 1.51 to 19.08The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.
  • Gemcabene 300 mg vs Placebo · Regression, Logistic · p = 0.1070 (Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.) · Odds ratio (or): 2.57 · 95% CI 0.82 to 8.07The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.
  • Gemcabene 600 mg vs Placebo · Regression, Logistic · p = 0.0865 (Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.) · Odds ratio (or): 2.57 · 95% CI 0.87 to 7.53
  • Gemcabene 300 mg vs Placebo · Regression, Logistic · p = 0.3990 (Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.) · Odds ratio (or): 1.57 · 95% CI 0.55 to 4.48The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.
  • Gemcabene 600 mg vs Placebo · Regression, Logistic · p = 0.0772 (Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.) · Odds ratio (or): 2.75 · 95% CI 0.90 to 8.42The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.
  • Gemcabene 300 mg vs Placebo · Regression, Logistic · p = 0.4315 (Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.) · Odds ratio (or): 1.54 · 95% CI 0.53 to 4.48The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.

Adverse events

Collected over Baseline to End of study (up to Day 113). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gemcabene 600 mg0/30 (0%)0/30 (0%)16/30 (53.3%)
Gemcabene 300 mg0/30 (0%)0/30 (0%)14/30 (46.7%)
Placebo0/31 (0%)1/31 (3.2%)20/31 (64.5%)
Most frequent serious events
Most frequent serious events
EventGemcabene 600 mgGemcabene 300 mgPlacebo
CystitisInfections and infestations0/300/301/31
Most frequent other events
Showing 10 of 84
Most frequent other events
EventGemcabene 600 mgGemcabene 300 mgPlacebo
Vulvovaginal burning sensationReproductive system and breast disorders1/50/10/12
Vulvovaginal pruritusReproductive system and breast disorders1/50/10/12
DiarrhoeaGastrointestinal disorders1/300/304/31
Urinary tract infectionInfections and infestations1/301/303/31
Vaginal infectionInfections and infestations0/50/11/12
Breast cystNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/50/11/12
Breast massReproductive system and breast disorders0/50/11/12
NauseaGastrointestinal disorders2/300/301/31
ContusionInjury, poisoning and procedural complications2/300/300/31
Blood creatine phosphokinase increasedInvestigations2/301/300/31

Baseline characteristics

Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

Age, Continuous
Age, Continuous(years)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Mean56.3 ± 9.1051.5 ± 9.5054.6 ± 12.0654.1 ± 10.40
Sex: Female, Male
Sex: Female, Male(Participants)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Female511218
Male25291973
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Hispanic or Latino12131035
Not Hispanic or Latino18172156
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
American Indian or Alaska Native0000
Asian0123
Native Hawaiian or Other Pacific Islander0000
Black or African American2024
White28292582
More than one race0000
Unknown or Not Reported0022
Triglycerides [TG]
Triglycerides [TG](Milligram per deciliter (mg/dL))Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Median637 (456.7 to 1477.7)641.17 (387.0 to 1658.7)658.33 (442.0 to 1205.7)643.0 (387.0 to 1658.7)
Non-high-density lipoprotein cholesterol (non-HDL-C)
Non-high-density lipoprotein cholesterol (non-HDL-C)(mg/dL)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Median238.75 (121.5 to 324.5)190.0 (104.0 to 448.5)201.00 (80.5 to 373.5)205.00 (80.5 to 448.5)
High-density lipoprotein cholesterol (HDL-C)
High-density lipoprotein cholesterol (HDL-C)(mg/dL)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Median28.50 (17.0 to 46.0)28.00 (19.0 to 39.0)29.00 (17.0 to 56.0)28.0 (17.0 to 56.0)
Very low-density lipoprotein cholesterol (VLDL-C)
Very low-density lipoprotein cholesterol (VLDL-C)(mg/dL)Gemcabene 600 mgGemcabene 300 mgPlaceboTotal
Median108.50 (54.0 to 230.0)102.50 (27.0 to 359.0)117.00 (51.0 to 350.0)110.00 (27.0 to 359.0)

20 further baseline measures are reported on the registry.

08

Study locations

49 sites
  • Appalachian Research Associates
    Fort Payne, Alabama 35967, United States
  • Del Sol Research Mangagement, LLC
    Tucson, Arizona 85710, United States
  • Westside Medical Associates of Los Angeles
    Beverly Hills, California 90211, United States
  • Hope Clinical Research
    Canoga Park, California 91303, United States
  • SC Clinical Research
    Garden Grove, California 92844, United States
  • National Research Institute
    Huntington Park, California 90255, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • Paradigm Clinical Research
    San Diego, California 92117, United States
  • Paradigm Research
    Wheat Ridge, Colorado 80033, United States
  • Excel Medical Research
    Boca Raton, Florida 33434, United States
  • Meridien Research
    Bradenton, Florida 34201, United States
  • Direct Helpers Research Center
    Hialeah, Florida 33012, United States
  • Indago Research and Health Center
    Hialeah, Florida 33012, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Sunrise Medical Research
    Lauderdale Lakes, Florida 33319, United States
  • AR Developoment Solutions
    Miami Lakes, Florida 33014, United States
  • San Marcus Research Clinic, Inc.
    Miami, Florida 33015, United States
  • Millenium Clinical Research, Inc.
    Miami, Florida 33125, United States
  • Medcare Research
    Miami, Florida 33165, United States
  • Soma Medical Research
    West Palm Beach, Florida 33406, United States
  • Evanston Premier Clinical Research
    Evanston, Illinois 60201, United States
  • Midwest Institute for Clinical Research, Inc.
    Indianapolis, Indiana 46260, United States
  • Richard Lochamy, M.D.
    Junction City, Kansas 66441, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • L-MARC Research Center
    Louisville, Kentucky 40213, United States
  • Clinical Trials Management, LLC
    Covington, Louisiana 70433, United States
  • Clinical Trials Management, LLC
    Metairie, Louisiana 70006, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • University of Michigan Health Systems
    Ann Arbor, Michigan 48105, United States
  • Elite Clinical Research
    Jackson, Mississippi 39202, United States
  • Clinical Research of South Nevada
    Las Vegas, Nevada 89121, United States
  • CHEAR Center, LLC
    Bronx, New York 10455, United States
  • Advantage Clinical Trials
    Bronx, New York 10468, United States
  • Eastern Carolina Medical Clinic
    Benson, North Carolina 27504, United States
  • Physicians East, NA
    Farmville, North Carolina 27828, United States
  • Physicians East, NA
    Greenville, North Carolina 27834, United States
  • Cary Medical Clinic
    Morrisville, North Carolina 27560, United States
  • Optimed Research
    Columbus, Ohio 43235, United States
  • PriMed Clinical Research
    Dayton, Ohio 45419, United States
  • Green and Seidner Family Practice Associates
    Lansdale, Pennsylvania 19446, United States
  • BTC of Lincoln
    Lincoln, Rhode Island 02865, United States
  • Carolinas Research Partners, LLC
    Rock Hill, South Carolina 29732, United States
  • Airline Complete Healthcare
    Houston, Texas 77091, United States
  • Sante Clinical Research
    Kerrville, Texas 78028, United States
  • FMC Science
    Lampasas, Texas 76550, United States
  • Clinical Investigations of Texas
    Plano, Texas 75075, United States
  • Sun Research Institute
    San Antonio, Texas 78215, United States
  • Clinical Investigation Specialists
    Kenosha, Wisconsin 53142, United States
  • Ecogene-21
    Chicoutimi, Quebec G7H 7K9, Canada
09

References and documents

Study documents

  • Study protocol · Mar 17, 2017
  • Statistical analysis plan · May 2, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02944383
Lead sponsor
NeuroBo Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Oct 25, 2016
Start date
Dec 2016
Primary completion
Jan 11, 2018
Completion
May 9, 2018
Results posted
Jun 25, 2020
Last update
Jun 25, 2020

Study contacts

Lee Golden, MD
study director · NeuroBo Pharmaceuticals Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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