A Phase 3 interventional study of Volanesorsen and Placebo in Hypertriglyceridemia, sponsored by Ionis Pharmaceuticals, Inc.. Completed at 45 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
302 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 114 is above the median of 66 across 265 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Ionis Pharmaceuticals, Inc. is the lead sponsor of 118 studies on the registry; 10 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 22 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Drug: Placebo
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Drug: Volanesorsen
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Drug: Volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.
Also known as: ISIS 304801
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
Time frame: Baseline to 3 months
Absolute Change in Fasting TG From Baseline to Month 3
Time frame: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Time frame: Baseline to 3 months
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Time frame: Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
mg/dL = milligrams per deciliter
Time frame: Baseline to 3 months
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
HOMA-IR was calculated using the following formula: fasting insulin micro-international units per millimeter (μIU/mL) x fasting glucose mg/dL\]/405. A negative change from baseline indicates improvement; a positive change from baseline indicates worsening.
Time frame: Baseline to 3 and 6 months
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Time frame: Baseline to 3 and 6 months
A total of 114 participants were randomized at multiple study centers worldwide.
| Milestone | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 |
|---|---|---|---|
| Started | 38 | 25 | 50 |
| Completed | 34 | 24 | 27 |
| Not completed | 4 | 1 | 23 |
| Withdrew: Adverse event or serious adverse event | 3 | 1 | 14 |
| Withdrew: Withdrawal by subject | 1 | 0 | 3 |
| Withdrew: Investigator judgement | 0 | 0 | 1 |
| Withdrew: Reason not specified | 0 | 0 | 5 |
| percent change | Placebo | Volanesorsen Total |
|---|---|---|
| Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 | -0.9 (-13.9 to 12.2) | -71.2 (-79.3 to -63.2) |
| mg/dL | Placebo | Volanesorsen Total |
|---|---|---|
| Absolute Change in Fasting TG From Baseline to Month 3 | 74 (-138 to 285) | -869 (-1018 to -720) |
| Participants | Placebo | Volanesorsen Total |
|---|---|---|
| Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3 | 5 | 65 |
| percent change | Placebo | Volanesorsen Total |
|---|---|---|
| Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline | 4.4 (-5.2 to 14.0) | 61.2 (54.2 to 68.3) |
mg/dL = milligrams per deciliter
| Participants | Placebo | Volanesorsen Total |
|---|---|---|
| Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3 | 0 | 11 |
HOMA-IR was calculated using the following formula: fasting insulin micro-international units per millimeter (μIU/mL) x fasting glucose mg/dL\]/405. A negative change from baseline indicates improvement; a positive change from baseline indicates worsening.
| score | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 |
|---|---|---|---|
| Month 3 | -0.29 ± 3.12 | 1.53 ± 4.89 | -0.45 ± 4.97 |
| Month 6 | -0.37 ± 3.18 | 1.54 ± 7.69 | 0.56 ± 2.97 |
| percentage | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 |
|---|---|---|---|
| Month 3 | -0.0 ± 0.5 | 0.4 ± 0.6 | 0.1 ± 0.5 |
| Month 6 | -0.2 ± 0.6 | 0.8 ± 0.9 | 0.3 ± 0.9 |
Collected over Up to approximately 39 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/38 (0%) | 4/38 (10.5%) | 31/38 (81.6%) |
| Volanesorsen 300 mg Weekly | 0/25 (0%) | 2/25 (8%) | 24/25 (96%) |
| Volanesorsen 300 mg Biweekly, Post Week 13 | 0/50 (0%) | 6/50 (12%) | 49/50 (98%) |
| Event | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 |
|---|---|---|---|
| Pancreatitis acuteGastrointestinal disorders | 2/38 | 1/25 | 0/50 |
| Ulna fractureInjury, poisoning and procedural complications | 0/38 | 1/25 | 0/50 |
| Ileus paralyticGastrointestinal disorders | 1/38 | 0/25 | 0/50 |
| Pancreatitis relapsingGastrointestinal disorders | 1/38 | 0/25 | 0/50 |
| CholelithiasisHepatobiliary disorders | 1/38 | 0/25 | 0/50 |
| Pancreas infectionInfections and infestations | 1/38 | 0/25 | 0/50 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/38 | 0/25 | 0/50 |
| VertigoEar and labyrinth disorders | 0/38 | 0/25 | 1/50 |
| Small intestinal obstructionGastrointestinal disorders | 0/38 | 0/25 | 1/50 |
| Non-cardiac chest painGeneral disorders | 0/38 | 0/25 | 1/50 |
| Event | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 |
|---|---|---|---|
| Injection site erythemaGeneral disorders | 2/38 | 23/25 | 38/50 |
| Injection site painGeneral disorders | 2/38 | 10/25 | 29/50 |
| Injection site swellingGeneral disorders | 1/38 | 12/25 | 24/50 |
| Injection site discolourationGeneral disorders | 0/38 | 12/25 | 11/50 |
| Injection site pruritusGeneral disorders | 0/38 | 10/25 | 17/50 |
| NasopharyngitisInfections and infestations | 5/38 | 8/25 | 4/50 |
| Injection site indurationGeneral disorders | 2/38 | 7/25 | 11/50 |
| Red blood cell sedimentation rate increasedInvestigations | 4/38 | 6/25 | 5/50 |
| Injection site discomfortGeneral disorders | 1/38 | 2/25 | 11/50 |
| Injection site bruisingGeneral disorders | 1/38 | 1/25 | 10/50 |
The full analysis set (FAS) included all participants who were randomized, received at least one dose of study drug, and had a baseline triglycerides (TG) assessment.
| Age, Continuous(years) | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 | Total |
|---|---|---|---|---|
| Mean | 53 ± 10 | 50 ± 9 | 51 ± 11 | 51 ± 10 |
| Sex: Female, Male(Participants) | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 | Total |
|---|---|---|---|---|
| Female | 8 | 5 | 14 | 27 |
| Male | 30 | 20 | 36 | 86 |
| Race/Ethnicity, Customized(Participants) | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 2 |
| Not Hispanic or Latino | 37 | 24 | 50 | 111 |
| Race/Ethnicity, Customized(Participants) | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 | Total |
|---|---|---|---|---|
| White | 33 | 25 | 47 | 105 |
| Asian | 3 | 0 | 1 | 4 |
| American Indian or Alaskan Native | 0 | 0 | 1 | 1 |
| Other Race | 1 | 0 | 1 | 2 |
| Multiple | 1 | 0 | 0 | 1 |
| Fasting Triglycerides(milligrams per deciliter (mg/dL)) | Placebo | Volanesorsen 300 mg Weekly | Volanesorsen 300 mg Biweekly, Post Week 13 | Total |
|---|---|---|---|---|
| Mean | 1414 ± 1253 | 1046 ± 560 | 1251 ± 838 | 1261 ± 955 |
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ISIS 304801