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CompletedNCT04720534SHASTA-2Updated Mar 24, 2026Results posted

Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

A Phase 2 interventional study of ARO-APOC3 and Placebo in Severe Hypertriglyceridemia, sponsored by Arrowhead Pharmaceuticals. Completed at 74 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Arrowhead Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
229
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.

02

Conditions studied

  • Severe Hypertriglyceridemia

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03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 229 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 10 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.

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

  • Based on medical history, evidence of triglycerides (TG) ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
  • Fasting TG ≥ 500 mg/dL at Screening
  • Willing to follow diet counseling per Investigator judgment based on local standard of care
  • Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
  • Willing to provide written informed consent and to comply with study requirements

Exclusion criteria

Exclusion Criteria:

  • Active pancreatitis within 12 weeks prior to first dose
  • Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
  • Acute coronary syndrome event within 24 weeks of first dose
  • Major surgery within 12 weeks of first dose
  • Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
  • Uncontrolled hypertension
  • Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Hemorrhagic stroke within 24 weeks of first dose
  • Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
229 participants (actual)

Study arms

  • Experimental
    Placebo, Day 1 and Week 12

    Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.

    Drug: Placebo

  • Experimental
    ARO-APOC3 10 mg

    Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

    Drug: ARO-APOC3

  • Experimental
    ARO-APOC3 25 mg

    Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

    Drug: ARO-APOC3

  • Experimental
    ARO-APOC3 50 mg

    Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

    Drug: ARO-APOC3

Interventions

  • DrugARO-APOC3

    2 doses of ARO-APOC3 by subcutaneous (sc) injection

  • DrugPlacebo

    calculated volume to match active treatment by sc injection

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Percent Change From Baseline Over Time Through Week 48 in Fasting TG

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

  2. Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III

    Time frame: Baseline, Week 24

  3. Percent Change From Baseline Over Time Through Week 48 in ApoC-III

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

  4. Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: Baseline, Week 24

  5. Percent Change From Baseline Over Time Through Week 48 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

  6. Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, Week 24

  7. Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

  8. Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)

    Time frame: Baseline, Week 24

  9. Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

  10. Percent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)

    LDL-C analyses used both Martin-Hopkins methodology and ultracentrifugation. The Martin-Hopkins formula is a method for calculating LDL-C that improves accuracy by using an adjustable factor for estimating very-low-density lipoprotein (VLDL) cholesterol cholesterol based on triglyceride and non-HDL cholesterol levels.

    Time frame: Baseline, Week 24

  11. Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C

    LDL-C analyses used both Martin-Hopkins methodology (MHM) and ultracentrifugation (UC). The Martin-Hopkins formula is a method for calculating LDL-C that improves accuracy by using an adjustable factor for estimating very-low-density lipoprotein (VLDL) cholesterol cholesterol based on triglyceride and non-HDL cholesterol levels.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

  12. Change From Baseline in Plasma Concentrations of ARO-APOC3 Over TimeThrough Week 12

    Time frame: Day 1: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose

  13. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. TEAEs are AEs that occur following investigational product (IP) administration or a pre-existing condition exacerbated following IP administration.

    Time frame: From first dose of study drug up to Week 48

07

Results

Posted Mar 24, 2026

Participant flow

There were 76 study centers in 8 countries (Australia, Canada, Germany, Hungary, The Netherlands, New Zealand, Poland, and the United States \[US\]).

Participant flow — Overall Study
MilestonePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Started62555557
Completed58505253
Not completed4534
Withdrew: Withdrawal by subject3111
Withdrew: Physician decision0001
Withdrew: Other, not specified0201
Withdrew: Adverse event0101
Withdrew: Lost to follow-up1120

Outcome measures

PrimaryPercent Change From Baseline at Week 24 in Fasting Triglycerides (TG)
Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage change
Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)-17.2 ± 5.27-66.0 ± 5.61-70.2 ± 5.51-74.2 ± 5.44
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -48.8 · 95% CI -64.0 to -33.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -53.1 · 95% CI -68.1 to -38.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -57.0 · 95% CI -71.9 to -42.1
SecondaryPercent Change From Baseline Over Time Through Week 48 in Fasting TG
Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Week 47.2 ± 4.61-63.3 ± 4.88-79.5 ± 4.81-77.6 ± 4.72
Week 8-0.7 ± 5.19-54.0 ± 5.46-73.2 ± 5.45-72.8 ± 5.34
Week 12-7.3 ± 7.05-53.9 ± 7.35-64.9 ± 7.29-70.3 ± 7.24
Week 16-2.9 ± 5.91-70.5 ± 6.32-80.1 ± 6.17-76.3 ± 6.15
Week 202.4 ± 6.66-67.7 ± 7.07-75.3 ± 7.02-75.6 ± 6.91
Week 24-17.2 ± 5.27-66.0 ± 5.61-70.2 ± 5.51-74.2 ± 5.44
Week 28-11.7 ± 5.83-60.0 ± 6.33-70.3 ± 6.23-70.8 ± 6.11
Week 36-7.6 ± 9.08-37.7 ± 9.70-64.0 ± 9.54-53.6 ± 9.35
Week 48-6.6 ± 7.71-31.4 ± 8.20-58.0 ± 8.15-53.4 ± 7.97
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -70.5 · 95% CI -83.7 to -57.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · MMRM · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -86.7 · 95% CI -99.8 to -73.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -84.9 · 95% CI -97.9 to -71.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -53.3 · 95% CI -68.1 to -38.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -72.5 · 95% CI -87.3 to -57.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed models repeated measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -72.0 · 95% CI -86.7 to -57.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -46.6 · 95% CI -66.7 to -26.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -57.6 · 95% CI -77.5 to -37.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -63.0 · 95% CI -82.9 to -43.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -67.6 · 95% CI -84.6 to -50.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -77.2 · 95% CI -94.1 to -60.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -73.3 · 95% CI -90.2 to -56.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -70.1 · 95% CI -89.2 to -50.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -77.7 · 95% CI -96.8 to -58.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -78.0 · 95% CI -96.9 to -59.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -48.8 · 95% CI -64.0 to -33.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -53.1 · 95% CI -68.1 to -38.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -57.0 · 95% CI -71.9 to -42.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -48.3 · 95% CI -65.3 to -31.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -58.5 · 95% CI -75.3 to -41.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -59.0 · 95% CI -75.7 to -42.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0243 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -30.1 · 95% CI -56.3 to -3.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -56.4 · 95% CI -82.3 to -30.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0005 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -46.0 · 95% CI -71.7 to -20.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0283 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -24.9 · 95% CI -47.1 to -2.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -51.5 · 95% CI -73.6 to -29.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <.0001 (MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.) · Difference: -46.8 · 95% CI -68.7 to -25.0
SecondaryPercent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III
Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage change
Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III114.2 ± 73.08-69.6 ± 76.90-73.7 ± 76.04-79.4 ± 73.19
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.076 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -183.8 · 95% CI -387.0 to 19.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0677 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -187.9 · 95% CI -389.6 to 13.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0568 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -193.6 · 95% CI -392.9 to 5.6
SecondaryPercent Change From Baseline Over Time Through Week 48 in ApoC-III
Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Week 4209.3 ± 73.06-67.3 ± 76.79-84.4 ± 76.00-84.6 ± 73.12
Week 8146.3 ± 73.06-59.8 ± 76.76-78.8 ± 76.03-79.9 ± 73.14
Week 12122.2 ± 73.13-55.5 ± 76.79-71.8 ± 76.04-73.2 ± 73.21
Week 16134.4 ± 73.09-77.1 ± 76.90-86.4 ± 76.04-87.1 ± 73.25
Week 20118.8 ± 73.11-71.7 ± 76.87-81.2 ± 76.13-84.0 ± 73.26
Week 24114.2 ± 73.08-69.6 ± 76.90-73.7 ± 76.04-79.4 ± 73.19
Week 28140.2 ± 73.06-64.4 ± 76.89-71.9 ± 76.09-74.7 ± 73.21
Week 36152.0 ± 73.13-50.2 ± 76.92-60.9 ± 76.12-59.9 ± 73.21
Week 48135.8 ± 73.14-34.5 ± 76.89-49.6 ± 76.16-48.3 ± 73.25
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0078 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -276.6 · 95% CI -479.6 to -73.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0045 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -293.7 · 95% CI -495.3 to -92.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0040 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -293.9 · 95% CI -493.0 to -94.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0466 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -206.0 · 95% CI -409.0 to -3.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0288 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -225.1 · 95% CI -426.7 to -23.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0262 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -226.2 · 95% CI -425.3 to -27.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0861 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -177.6 · 95% CI -380.7 to 25.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0595 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -193.9 · 95% CI -395.7 to 7.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0548 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -195.3 · 95% CI -394.7 to 4.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0414 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -211.5 · 95% CI -414.7 to -8.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0320 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -220.8 · 95% CI -422.5 to -19.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0296 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -221.5 · 95% CI -420.9 to -22.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0659 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -190.6 · 95% CI -393.7 to 12.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0521 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -200.0 · 95% CI -401.8 to 1.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0462 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -202.8 · 95% CI -402.2 to -3.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0760 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -183.8 · 95% CI -387.0 to 19.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0677 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -187.9 · 95% CI -389.6 to 13.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0568 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -193.6 · 95% CI -392.9 to 5.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0484 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -204.6 · 95% CI -407.7 to -1.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0394 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -212.1 · 95% CI -413.8 to -10.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0346 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -214.9 · 95% CI -414.2 to -15.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0511 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -202.3 · 95% CI -405.5 to 1.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0387 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -213.0 · 95% CI -414.8 to -11.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0373 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -211.9 · 95% CI -411.3 to -12.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1002 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -170.2 · 95% CI -373.5 to 33.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0718 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -185.4 · 95% CI -387.3 to 16.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0703 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -184.0 · 95% CI -383.4 to 15.4
SecondaryPercent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage change
Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)-1.5 ± 3.76-29.4 ± 4.04-28.4 ± 3.90-21.7 ± 3.83
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -27.9 · 95% CI -38.6 to -17.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -26.9 · 95% CI -37.4 to -16.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0002 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -20.2 · 95% CI -30.6 to -9.7
SecondaryPercent Change From Baseline Over Time Through Week 48 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Week 46.3 ± 3.35-27.0 ± 3.57-34.7 ± 3.46-26.1 ± 3.37
Week 84.5 ± 3.77-19.7 ± 4.00-30.7 ± 3.92-20.7 ± 3.82
Week 121.4 ± 4.54-19.3 ± 4.77-30.0 ± 4.67-22.3 ± 4.61
Week 161.8 ± 3.73-27.9 ± 4.00-37.8 ± 3.87-23.7 ± 3.81
Week 205.7 ± 3.96-26.7 ± 4.22-34.6 ± 4.13-22.9 ± 4.04
Week 24-1.5 ± 3.76-29.4 ± 4.04-28.4 ± 3.90-21.7 ± 3.83
Week 28-2.3 ± 3.82-27.4 ± 4.14-31.3 ± 4.02-24.0 ± 3.92
Week 36-0.3 ± 4.57-19.2 ± 4.91-23.8 ± 4.78-13.1 ± 4.65
Week 480.5 ± 4.58-10.0 ± 4.92-23.0 ± 4.83-13.5 ± 4.69
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -33.4 · 95% CI -42.8 to -23.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -41.0 · 95% CI -50.3 to -31.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -32.4 · 95% CI -41.6 to -23.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -24.1 · 95% CI -34.8 to -13.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -35.2 · 95% CI -45.7 to -24.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -25.1 · 95% CI -35.6 to -14.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0017 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -20.7 · 95% CI -33.5 to -7.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -31.4 · 95% CI -44.1 to -18.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0003 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -23.6 · 95% CI -36.3 to -11.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -29.7 · 95% CI -40.3 to -19.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -39.5 · 95% CI -50.0 to -29.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -25.5 · 95% CI -35.8 to -15.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -32.5 · 95% CI -43.7 to -21.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -40.3 · 95% CI -51.4 to -29.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -28.6 · 95% CI -39.6 to -17.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -27.9 · 95% CI -38.6 to -17.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -26.9 · 95% CI -37.4 to -16.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0002 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -20.2 · 95% CI -30.6 to -9.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -25.1 · 95% CI -36.0 to -14.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -29.0 · 95% CI -39.7 to -18.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -21.7 · 95% CI -32.3 to -11.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0047 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -18.9 · 95% CI -32.0 to -5.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0004 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -23.5 · 95% CI -36.4 to -10.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0485 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -12.8 · 95% CI -25.6 to -0.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1150 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -10.5 · 95% CI -23.6 to 2.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0004 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -23.5 · 95% CI -36.5 to -10.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0324 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -14.0 · 95% CI -26.8 to -1.2
SecondaryPercent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)
Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage change
Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)10.6 ± 5.8754.2 ± 6.3262.8 ± 6.0967.6 ± 6.00
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 43.5 · 95% CI 26.8 to 60.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 52.2 · 95% CI 35.8 to 68.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 57.0 · 95% CI 40.7 to 73.3
SecondaryPercent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Week 44.3 ± 5.4853.4 ± 5.8676.2 ± 5.6788.1 ± 5.56
Week 86.2 ± 5.4545.4 ± 5.7973.5 ± 5.6667.7 ± 5.54
Week 1211.3 ± 5.5039.9 ± 5.8160.2 ± 5.6662.5 ± 5.59
Week 165.7 ± 5.7866.2 ± 6.2387.1 ± 5.9982.6 ± 5.94
Week 208.8 ± 6.2061.2 ± 6.6378.7 ± 6.4881.2 ± 6.36
Week 2410.6 ± 5.8754.2 ± 6.3262.8 ± 6.0967.6 ± 6.00
Week 2810.2 ± 5.5548.2 ± 6.0067.2 ± 5.8168.0 ± 5.70
Week 3611.7 ± 5.8334.5 ± 6.2951.1 ± 6.0947.2 ± 5.95
Week 486.1 ± 5.4023.5 ± 5.8032.4 ± 5.6537.8 ± 5.51
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 49.1 · 95% CI 33.6 to 64.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 71.9 · 95% CI 56.6 to 87.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 83.9 · 95% CI 68.7 to 99.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 39.3 · 95% CI 23.9 to 54.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 67.3 · 95% CI 52.1 to 82.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 61.5 · 95% CI 46.4 to 76.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0003 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 28.6 · 95% CI 13.1 to 44.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 48.9 · 95% CI 33.6 to 64.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 51.2 · 95% CI 35.9 to 66.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 60.5 · 95% CI 44.0 to 76.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 81.4 · 95% CI 65.2 to 97.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 76.9 · 95% CI 60.8 to 93.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 52.4 · 95% CI 34.8 to 70.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 69.9 · 95% CI 52.5 to 87.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Models Analysis · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 72.4 · 95% CI 55.1 to 89.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 43.5 · 95% CI 26.8 to 60.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 52.2 · 95% CI 35.8 to 68.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 57.0 · 95% CI 40.7 to 73.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 37.9 · 95% CI 22.2 to 53.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 57.0 · 95% CI 41.4 to 72.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 57.8 · 95% CI 42.4 to 73.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0075 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 22.8 · 95% CI 6.1 to 39.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 39.4 · 95% CI 23.0 to 55.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 35.5 · 95% CI 19.3 to 51.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0255 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 17.5 · 95% CI 2.2 to 32.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0007 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 26.3 · 95% CI 11.2 to 41.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 31.8 · 95% CI 16.8 to 46.8
SecondaryPercent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)
Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage change
Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)8.0 ± 5.856.0 ± 6.31-5.3 ± 6.060.7 ± 6.01
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.8155 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -2.0 · 95% CI -18.8 to 14.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1124 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -13.3 · 95% CI -29.8 to 3.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3791 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -7.3 · 95% CI -23.8 to 9.1
SecondaryPercent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Week 416.2 ± 6.70-2.3 ± 7.10-9.0 ± 6.95-1.9 ± 6.84
Week 816.0 ± 4.74-0.8 ± 4.97-7.2 ± 4.891.5 ± 4.82
Week 124.2 ± 3.700.5 ± 3.80-11.2 ± 3.74-1.3 ± 3.73
Week 165.3 ± 4.13-0.8 ± 4.34-13.1 ± 4.22-0.6 ± 4.20
Week 201.6 ± 3.98-0.7 ± 4.17-10.3 ± 4.104.4 ± 4.06
Week 248.0 ± 5.856.0 ± 6.31-5.3 ± 6.060.7 ± 6.01
Week 283.9 ± 3.70-1.3 ± 3.92-6.0 ± 3.830.6 ± 3.79
Week 368.9 ± 4.10-0.4 ± 4.352.5 ± 4.248.5 ± 4.17
Week 485.7 ± 4.066.4 ± 4.28-0.2 ± 4.212.4 ± 4.14
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0587 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -18.4 · 95% CI -37.6 to 0.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0094 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -25.2 · 95% CI -44.1 to -6.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0589 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -18.1 · 95% CI -36.8 to 0.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0139 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -16.8 · 95% CI -30.2 to -3.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0007 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -23.2 · 95% CI -36.4 to -9.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0307 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -14.5 · 95% CI -27.7 to -1.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.4824 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -3.7 · 95% CI -13.9 to 6.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0030 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -15.5 · 95% CI -25.6 to -5.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.2877 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -5.5 · 95% CI -15.6 to 4.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3028 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -6.1 · 95% CI -17.7 to 5.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0018 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -18.4 · 95% CI -29.8 to -6.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3101 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -5.9 · 95% CI -17.3 to 5.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.6866 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -2.3 · 95% CI -13.4 to 8.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0350 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -11.9 · 95% CI -23.0 to -0.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.6165 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 2.8 · 95% CI -8.2 to 13.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.8155 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -2.0 · 95% CI -18.8 to 14.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1124 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -13.3 · 95% CI -29.8 to 3.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3791 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -7.3 · 95% CI -23.8 to 9.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3255 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -5.2 · 95% CI -15.6 to 5.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0599 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -9.9 · 95% CI -20.2 to 0.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.5213 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -3.3 · 95% CI -13.6 to 6.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1147 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -9.3 · 95% CI -20.9 to 2.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.2727 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -6.4 · 95% CI -17.8 to 5.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9401 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -0.4 · 95% CI -11.8 to 10.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9041 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 0.7 · 95% CI -10.7 to 12.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3069 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -5.9 · 95% CI -17.2 to 5.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.5655 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -3.3 · 95% CI -14.5 to 8.0
SecondaryPercent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)

LDL-C analyses used both Martin-Hopkins methodology and ultracentrifugation. The Martin-Hopkins formula is a method for calculating LDL-C that improves accuracy by using an adjustable factor for estimating very-low-density lipoprotein (VLDL) cholesterol cholesterol based on triglyceride and non-HDL cholesterol levels.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage change
Percent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Martin-Hopkins methodology-5.5 ± 123.7301.9 ± 128.17-15.4 ± 120.302.0 ± 123.04
Ultracentrifugation18.0 ± 10.4849.0 ± 11.0643.7 ± 10.7678.2 ± 10.60
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0737 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 307.4 · 95% CI -29.8 to 644.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9525 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -9.9 · 95% CI -337.4 to 317.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9644 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 7.5 · 95% CI -323.3 to 338.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0395 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 31.0 · 95% CI 1.5 to 60.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0825 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 25.8 · 95% CI -3.4 to 54.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = < 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 60.3 · 95% CI 31.3 to 89.2
SecondaryPercent Change From Baseline Over Time Through Week 48 in Fasting LDL-C

LDL-C analyses used both Martin-Hopkins methodology (MHM) and ultracentrifugation (UC). The Martin-Hopkins formula is a method for calculating LDL-C that improves accuracy by using an adjustable factor for estimating very-low-density lipoprotein (VLDL) cholesterol cholesterol based on triglyceride and non-HDL cholesterol levels.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
MHM Week 4-29.3 ± 123.78267.3 ± 128.13-13.5 ± 120.280.6 ± 123.00
MHM Week 8-11.3 ± 123.74297.4 ± 128.11-11.7 ± 120.295.3 ± 123.01
MHM Week 12-13.6 ± 123.75300.7 ± 128.12-17.3 ± 120.293.2 ± 123.02
MHM Week 16-14.3 ± 123.72340.3 ± 128.15-20.4 ± 120.295.6 ± 123.04
MHM Week 20-7.3 ± 123.72306.7 ± 128.15-17.4 ± 120.314.9 ± 123.05
MHM Week 24-5.5 ± 123.67301.9 ± 128.17-15.4 ± 120.302.0 ± 123.04
MHM Week 28-12.1 ± 123.68283.2 ± 128.20-12.1 ± 120.34-4.7 ± 123.06
MHM Week 36-5.5 ± 123.73254.7 ± 128.28-0.7 ± 120.381.6 ± 123.10
MHM Week 48-11.5 ± 123.77286.5 ± 128.34-9.0 ± 120.44-5.3 ± 123.12
UC Week 44.4 ± 9.6550.3 ± 10.1047.3 ± 9.8869.1 ± 9.67
UC Week 815.8 ± 10.4449.8 ± 10.9245.8 ± 10.7365.4 ± 10.51
UC Week 1217.1 ± 10.1750.9 ± 10.5736.0 ± 10.3865.8 ± 10.22
UC Week 1619.3 ± 12.1462.6 ± 12.8041.7 ± 12.4687.1 ± 12.31
UC Week 2016.8 ± 11.7962.7 ± 12.3842.3 ± 12.1685.9 ± 11.93
UC Week 2418.0 ± 10.4849.0 ± 11.0643.7 ± 10.7678.2 ± 10.60
UC Week 2815.4 ± 10.1450.8 ± 10.7642.3 ± 10.5161.6 ± 10.30
UC Week 3618.4 ± 9.8935.5 ± 10.4751.5 ± 10.2061.3 ± 9.97
UC Week 4821.3 ± 10.7333.5 ± 11.3634.4 ± 11.1444.6 ± 10.87
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0843 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 296.7 · 95% CI -40.6 to 633.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9240 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 15.9 · 95% CI -311.7 to 343.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.8587 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 29.9 · 95% CI -301.0 to 360.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0726 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 308.7 · 95% CI -28.5 to 645.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9981 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -0.4 · 95% CI -328.0 to 327.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9214 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 16.6 · 95% CI -314.3 to 347.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0676 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 314.3 · 95% CI -22.9 to 651.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9819 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -3.8 · 95% CI -331.4 to 323.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9205 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 16.8 · 95% CI -314.1 to 347.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0394 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 354.6 · 95% CI 17.4 to 691.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9707 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -6.1 · 95% CI -333.7 to 321.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9057 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 19.9 · 95% CI -311.0 to 350.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0678 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 314.0 · 95% CI -23.2 to 651.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9515 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -10.1 · 95% CI -337.7 to 317.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9423 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 12.2 · 95% CI -318.7 to 343.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0737 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 307.4 · 95% CI -29.8 to 644.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9525 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -9.9 · 95% CI -337.4 to 317.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9644 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 7.5 · 95% CI -323.3 to 338.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0858 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 295.2 · 95% CI -42.0 to 632.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9998 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 0.0 · 95% CI -327.5 to 327.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9648 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 7.4 · 95% CI -323.4 to 338.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1299 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 260.3 · 95% CI -77.1 to 597.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9772 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 4.8 · 95% CI -322.9 to 332.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9663 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 7.1 · 95% CI -323.9 to 338.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0832 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 298.0 · 95% CI -39.5 to 635.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9881 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 2.5 · 95% CI -325.4 to 330.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.9703 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 6.3 · 95% CI -324.8 to 337.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0010 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 45.8 · 95% CI 18.8 to 72.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0018 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 42.8 · 95% CI 16.1 to 69.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 64.7 · 95% CI 38.2 to 91.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0229 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 34.0 · 95% CI 4.8 to 63.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0426 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 30.0 · 95% CI 1.0 to 59.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0008 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 49.6 · 95% CI 20.9 to 78.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0201 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 33.7 · 95% CI 5.3 to 62.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1873 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 18.9 · 95% CI -9.3 to 47.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0007 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 48.7 · 95% CI 20.7 to 76.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0139 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 43.2 · 95% CI 8.9 to 77.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1943 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 22.4 · 95% CI -11.5 to 56.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 67.7 · 95% CI 34.0 to 101.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0071 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 45.9 · 95% CI 12.6 to 79.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1293 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 25.5 · 95% CI -7.5 to 58.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 69.1 · 95% CI 36.4 to 101.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0395 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 31.0 · 95% CI 1.5 to 60.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0825 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 25.8 · 95% CI -3.4 to 54.9
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 60.3 · 95% CI 31.3 to 89.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0155 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 35.4 · 95% CI 6.8 to 64.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0622 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 26.9 · 95% CI -1.4 to 55.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0013 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 46.3 · 95% CI 18.2 to 74.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.2262 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 17.1 · 95% CI -10.7 to 45.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0185 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 33.1 · 95% CI 5.6 to 60.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.0021 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 42.9 · 95% CI 15.7 to 70.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = 0.4284 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 12.2 · 95% CI -18.1 to 42.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = 0.3900 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 13.1 · 95% CI -16.9 to 43.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = 0.1242 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: 23.2 · 95% CI -6.4 to 52.9
SecondaryChange From Baseline in Plasma Concentrations of ARO-APOC3 Over TimeThrough Week 12
Time frame:
Day 1: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose
Reported as:
Mean · ng/mL
Change From Baseline in Plasma Concentrations of ARO-APOC3 Over TimeThrough Week 12
ng/mLARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Day 1, Pre-Dose0.000 ± 0.00000.000 ± 0.00000.000 ± 0.0000
Day 1, 15 Minutes Post-Dose10.258 ± 12.474121.207 ± 21.798234.352 ± 27.3986
Day 1, 1 Hour Post-Dose18.124 ± 18.176037.396 ± 27.984958.508 ± 29.0222
Day 1, 3 Hours Post-Dose20.217 ± 16.812750.596 ± 53.327058.493 ± 30.5510
Day 1, 6 Hours Post-Dose17.147 ± 14.614551.813 ± 44.261064.019 ± 26.3749
Day 1, 24 Hours Post-Dose7.921 ± 16.918110.316 ± 11.585211.587 ± 6.4288
Week 12, Pre-Dose0.000 ± 0.00000.000 ± 0.00000.000 ± 0.0000
Week 12, 15 Minutes Post-Dose10.188 ± 9.402423.576 ± 29.171338.500 ± 32.4047
Week 12, 1 Hour Post-Dose17.090 ± 12.763635.513 ± 26.549157.939 ± 26.8754
Week 12, 3 Hours Post-Dose15.101 ± 9.515642.591 ± 39.080865.482 ± 44.5255
Week 12, 6 Hours Post-Dose11.131 ± 6.689456.230 ± 52.434573.444 ± 42.1339
Week 12, 24 Hours Post-Dose3.143 ± 5.52716.241 ± 7.582012.125 ± 8.5500
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. TEAEs are AEs that occur following investigational product (IP) administration or a pre-existing condition exacerbated following IP administration.

Time frame:
From first dose of study drug up to Week 48
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
All TEAEs43433649
Treatment-related TEAEs813810
Serious TEAEs10427
TEAEs leading to study drug discontinuation0100
Deaths0000
Post-hocAd Hoc Analysis: Percent Change From Baseline at Week 24 and Over Time Through Week 48 in ApoC-III
Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Reported as:
Least squares mean · percentage change
Ad Hoc Analysis: Percent Change From Baseline at Week 24 and Over Time Through Week 48 in ApoC-III
percentage changePlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Week 47.0 ± 3.88-65.1 ± 4.04-82.9 ± 3.94-83.2 ± 3.81
Week 84.7 ± 4.19-57.3 ± 4.36-77.2 ± 4.26-78.7 ± 4.14
Week 120.0 ± 4.79-53.2 ± 4.97-70.3 ± 4.84-72.2 ± 4.74
Week 162.8 ± 3.94-74.8 ± 4.13-84.9 ± 4.00-86.3 ± 3.92
Week 207.8 ± 4.60-69.9 ± 4.81-79.7 ± 4.72-82.6 ± 4.60
Week 24-0.8 ± 4.29-68.1 ± 4.51-72.1 ± 4.37-78.2 ± 4.26
Week 28-2.2 ± 4.19-63.0 ± 4.42-70.2 ± 4.31-73.2 ± 4.19
Week 360.2 ± 4.98-48.5 ± 5.23-59.1 ± 5.10-58.3 ± 4.95
Week 485.6 ± 6.19-33.7 ± 6.48-48.0 ± 6.37-46.8 ± 6.19
Statistical analysis
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -72.1 · 95% CI -82.9 to -61.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -89.9 · 95% CI -100.5 to -79.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -90.2 · 95% CI -100.8 to -79.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -62.1 · 95% CI -73.7 to -50.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -82.0 · 95% CI -93.5 to -70.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -83.4 · 95% CI -94.9 to -72.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -53.2 · 95% CI -66.6 to -39.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -70.3 · 95% CI -83.6 to -57.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -72.2 · 95% CI -85.3 to -59.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -77.7 · 95% CI -88.7 to -66.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -87.8 · 95% CI -98.6 to -77.0
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -89.2 · 95% CI -99.9 to -78.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -77.7 · 95% CI -90.6 to -64.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -87.5 · 95% CI -100.3 to -74.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -90.4 · 95% CI -103.1 to -77.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -67.3 · 95% CI -79.3 to -55.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -71.3 · 95% CI -83.2 to -59.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -77.3 · 95% CI -89.1 to -65.6
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -60.8 · 95% CI -72.6 to -49.1
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -68.0 · 95% CI -79.6 to -56.3
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -71.0 · 95% CI -82.5 to -59.5
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -48.7 · 95% CI -62.8 to -34.7
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -59.3 · 95% CI -73.1 to -45.4
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -58.5 · 95% CI -72.2 to -44.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 10 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -39.3 · 95% CI -56.8 to -21.8
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 25 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -53.6 · 95% CI -70.9 to -36.2
  • Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (MMRM model includes treatment arm, study visit, stratification factor, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.) · Difference: -52.4 · 94% CI -69.5 to -35.2

Adverse events

Collected over Up to 48 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo, Day 1 and Week 120/61 (0%)10/61 (16.4%)44/61 (72.1%)
ARO-APOC3 10 mg0/54 (0%)4/54 (7.4%)44/54 (81.5%)
ARO-APOC3 25 mg0/55 (0%)2/55 (3.6%)36/55 (65.5%)
ARO-APOC3 50 mg0/56 (0%)7/56 (12.5%)50/56 (89.3%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventPlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
Abdominal painGastrointestinal disorders0/611/540/550/56
EnteritisGastrointestinal disorders0/611/540/550/56
ConcussionInjury, poisoning and procedural complications0/611/540/550/56
OsteoarthritisMusculoskeletal and connective tissue disorders0/611/540/551/56
Chronic lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/611/540/550/56
COVID-19Infections and infestations1/610/541/550/56
Pneumonia bacterialInfections and infestations0/610/541/550/56
SepsisInfections and infestations0/610/541/550/56
Pancreatitis acuteGastrointestinal disorders1/610/540/551/56
Small intestinal obstructionGastrointestinal disorders0/610/540/551/56
Most frequent other events
Showing 10 of 251
Most frequent other events
EventPlacebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mg
COVID-19Infections and infestations9/6111/549/559/56
HeadacheNervous system disorders3/618/546/552/56
Upper respiratory tract infectionInfections and infestations4/615/544/557/56
Urinary tract infectionInfections and infestations6/616/541/554/56
Type 2 diabetes mellitusMetabolism and nutrition disorders3/611/544/556/56
Back painMusculoskeletal and connective tissue disorders1/615/541/551/56
HypertensionVascular disorders4/610/542/555/56
DiarrhoeaGastrointestinal disorders5/613/541/551/56
ArthralgiaMusculoskeletal and connective tissue disorders5/613/541/554/56
BronchitisInfections and infestations2/614/540/554/56

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mgTotal
Mean55.8 ± 11.2252.9 ± 9.5556.0 ± 10.6454.3 ± 11.0054.9 ± 10.59
Sex: Female, Male
Sex: Female, Male(Participants)Placebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mgTotal
Female158121651
Male47474341178
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mgTotal
Hispanic or Latino1377633
Not Hispanic or Latino48474851194
Unknown or Not Reported11002
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo, Day 1 and Week 12ARO-APOC3 10 mgARO-APOC3 25 mgARO-APOC3 50 mgTotal
White56484853205
Black or African American12317
American Indian or Alaska Native10001
Asian31239
Native Hawaiian or Other Pacific Islander00202
Unknown01001
Other, Not Specified13004
08

Study locations

74 sites
  • Research Site 2
    Beverly Hills, California 90211, United States
  • Research Site 4
    Palm Springs, California 92292, United States
  • Research Site 5
    Boca Raton, Florida 33434, United States
  • Research Site 6
    Fort Lauderdale, Florida 33308, United States
  • Research Site 10
    Miami, Florida 33144, United States
  • Research Site 9
    Miami, Florida 33144, United States
  • Research Site 11
    Miami, Florida 33155, United States
  • Research Site 8
    Miami, Florida 33173, United States
  • Research Site 12
    Miami Springs, Florida 33166, United States
  • Research Site 14
    Port Orange, Florida 32127, United States
  • Research Site 16
    Dunwoody, Georgia 30338, United States
  • Research Site 17
    Arlington Heights, Illinois 60005, United States
  • Research Site 18
    Lexington, Kentucky 40503, United States
  • Research Site 20
    Minneapolis, Minnesota 55455, United States
  • Research Site 21
    Tupelo, Mississippi 38801, United States
  • Research Site 22
    Kalispell, Montana 59901, United States
  • Research Site 23
    Omaha, Nebraska 68114, United States
  • Research Site 24
    Las Vegas, Nevada 89121, United States
  • Research Site 25
    Long Island City, New York 11106, United States
  • Research Site 26
    New Windsor, New York 12553, United States
  • Research Site 27
    New York, New York 10029, United States
  • Research Site 29
    Morehead City, North Carolina 28557, United States
  • Research Site 30
    Fargo, North Dakota 58104, United States
  • Research Site 31
    Dayton, Ohio 45419, United States
  • Research Site 32
    Franklin, Ohio 45005, United States
  • Research Site 33
    Maumee, Ohio 43537, United States
  • Research Site 34
    Oklahoma City, Oklahoma 73135, United States
  • Research Site 35
    Greenville, South Carolina 29607, United States
  • Research Site 36
    Chattanooga, Tennessee 37421, United States
  • Research Site 38
    Houston, Texas 77030, United States
  • Research Site 39
    Houston, Texas 77099, United States
  • Research Site 40
    San Antonio, Texas 78249, United States
  • Research Site 41
    Manassas, Virginia 20110, United States
  • Research Site 43
    Perth, Nedlands 6009, Australia
  • Research Site 42
    Camperdown, New South Wales 2050, Australia
  • Research Site 44
    Brisbane, Queensland 4064, Australia
  • Research Site 45
    Sippy Downs, Queensland 4556, Australia
  • Research Site 46
    Adelaide, South Australia 5000, Australia
  • Research Site 47
    Clayton, Victoria 3168, Australia
  • Research Site 49
    Concord, Ontario L4K 4M2, Canada
  • Research Site 50
    London, Ontario N6A 5A5, Canada
  • Research Site 51
    Toronto, Ontario M4G 3E8, Canada
  • Research Site 52
    Chicoutimi, Quebec G7H5H6, Canada
  • Research Site 53
    Greenfield, Quebec J4V2G8, Canada
  • Research Site 54
    Montreal, Quebec H2W2T2, Canada
  • Research Site 55
    Aachen, 52074, Germany
  • Research Site 56
    Leipzig, 0 4103, Germany
  • Research Site 57
    Baja, 6500, Hungary
  • Research Site 58
    Baja, 6500, Hungary
  • Research Site 59
    Balatonföldvár, H-8230, Hungary
  • Research Site 60
    Békéscsaba, 5600, Hungary
  • Research Site 61
    Debrecen, 4032, Hungary
  • Research Site 62
    Gyöngyös, 3200, Hungary
  • Research Site 63
    Komárom, 2921, Hungary
  • Research Site 65
    Nyíregyháza, 4400, Hungary
  • Research Site 64
    Nyíregyháza, 4405, Hungary
  • Research Site 66
    Amsterdam, 1105 AZ, Netherlands
  • Research Site 67
    Dordrecht, 3318 AT, Netherlands
  • Research Site 68
    Sneek, 08601, Netherlands
  • Research Site 73
    Grafton, Auckland 1010, New Zealand
  • Research Site 69
    Christchurch, 8011, New Zealand
  • Research Site 70
    Hamilton, 3200, New Zealand
  • Research Site 71
    Papatoetoe, 2025, New Zealand
  • Research Site 72
    Rotorua, 3010, New Zealand
  • Research Site 74
    Bydgoszcz, 85-605, Poland
  • Research Site 75
    Elblag, 82-300, Poland
  • Research Site 76
    Gdynia, 81-157, Poland
  • Research Site 83
    Lodz, 94-048, Poland
  • Research Site 78
    Oświęcim, 32-600, Poland
  • Research Site 79
    Poznan, 61-655, Poland
  • Research Site 80
    Puławy, 24-100, Poland
  • Research Site 81
    Rzeszów, 35-055, Poland
  • Research Site 82
    Wołomin, 05-200, Poland
  • Research Site 77
    Łęczyca, 99-100, Poland
09

References and documents

Publications

  • Gaudet D, Pall D, Watts GF, Nicholls SJ, Rosenson RS, Modesto K, San Martin J, Hellawell J, Ballantyne CM. Plozasiran (ARO-APOC3) for Severe Hypertriglyceridemia: The SHASTA-2 Randomized Clinical Trial. JAMA Cardiol. 2024 Jul 1;9(7):620-630. doi: 10.1001/jamacardio.2024.0959. PubMed 38583092 ↗

Study documents

  • Study protocol · Jan 26, 2023
  • Statistical analysis plan · Sep 8, 2023

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 Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04720534
Lead sponsor
Arrowhead Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
May 31, 2021
Primary completion
Mar 9, 2023
Completion
Aug 31, 2023
Results posted
Mar 24, 2026
Last update
Mar 24, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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