15 completed, 3 recruiting, 2 withdrawn, 1 active not recruiting. 14 Phase 3, 9 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 8, Withdrawn 2, Active not recruiting 1, Not yet recruiting 1, Recruiting 1, Unknown 1 |
| Phase 2 | 9 | Completed 7, Recruiting 2 |
| Phase 1 | 1 | Completed 1 |
Follow Severe Hypertriglyceridemia: new trials by email Literature Review of Severe Hypertriglyceridemia trials Research Report on Severe Hypertriglyceridemia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia DR10624 Subcutaneous Injection, Icosapent Ethyl Oral Capsule, Matching Placebo Subcutaneous Injection - Severe Hypertriglyceridemia | Phase 3 | Not yet recruiting | Zhejiang Doer Biologics Co., Ltd. | 378 | 2026-08-01 | 2026-07-06 |
| A Study to Assess the Safety, Tolerability and Efficacy of ION775 ION775 - Hypertriglyceridemia, Severe Hypertriglyceridemia | Phase 2 | Recruiting | Ionis Pharmaceuticals, Inc. | 72 | 2026-05-12 | 2026-11-02 |
| A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia Solbinsiran, Placebo - Severe Hypertriglyceridemia | Phase 2 | Recruiting | Eli Lilly and Company | 60 | 2025-12-08 | 2026-11-04 |
| Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis Plozasiran, Placebo - Severe Hypertriglyceridemia | Phase 3 | Recruiting | Arrowhead Pharmaceuticals | 288 | 2025-04-24 | 2026-09-21 |
| A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia DR10624 Injection, Placebo - Severe Hypertriglyceridemia | Phase 2 | Completed | Zhejiang Doer Biologics Co., Ltd. | 79 | 2024-08-01 | 2026-01-13 |
| Study of Plozasiran in Adults With Severe Hypertriglyceridemia Plozasiran Injection, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | Arrowhead Pharmaceuticals | 311 | 2024-07-23 | 2026-10-09 |
| Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia Plozasiran Injection, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | Arrowhead Pharmaceuticals | 446 | 2024-07-22 | 2026-10-08 |
| To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia Pegozafermin, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | 89bio, Inc. | 369 | 2023-06-15 | 2026-07-07 |
| CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) Olezarsen - Severe Hypertriglyceridemia | Phase 3 | Active not recruiting | Ionis Pharmaceuticals, Inc. | 885 | 2022-12-13 | 2025-12-01 |
| A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia Olezarsen, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | Ionis Pharmaceuticals, Inc. | 446 | 2022-08-31 | 2025-10-22 |
| A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia Olezarsen, Placebo - Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease | Phase 2 | Completed | Ionis Pharmaceuticals, Inc. | 154 | 2022-05-09 | 2026-04-23 |
| A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia Olezarsen, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | Ionis Pharmaceuticals, Inc. | 617 | 2021-10-25 | 2026-02-10 |
| Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL Placebo, MAT9001 (omega-3 pentaenoic acid) - Severe Hypertriglyceridemia | Phase 3 | Withdrawn | Matinas Biopharma, Inc | 2021-06-01 | 2021-09-16 | |
| Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia ARO-APOC3, Placebo - Severe Hypertriglyceridemia | Phase 2 | Completed | Arrowhead Pharmaceuticals | 229 | 2021-05-31 | 2026-03-24 |
| Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia Pegozafermin, Placebo - Severe Hypertriglyceridemia | Phase 2 | Completed | 89bio, Inc. | 86 | 2020-09-01 | 2024-07-25 |
| A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia Gemcabene, Placebo - Severe Hypertriglyceridemia, Mixed Dyslipidaemia | Phase 2 | Completed | NeuroBo Pharmaceuticals Inc. | 91 | 2016-12-01 | 2020-06-25 |
| Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function K-877, Fenofibrate, Placebo (for K-877) - Severe Hypertriglyceridemia | Phase 3 | Completed | Kowa Research Institute, Inc. | 551 | 2016-11-28 | 2022-11-30 |
| Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment K-877, Fenofibrate, Placebo (for K-877) - Severe Hypertriglyceridemia | Phase 3 | Completed | Kowa Research Institute, Inc. | 471 | 2016-11-26 | 2022-10-28 |
| An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis Epanova, Lovaza - Severe Hypertriglyceridemia | Phase 1 | Completed | AstraZeneca | 30 | 2014-10-01 | 2016-06-20 |
| Epanova® for Lowering Very High Triglycerides placebo, omefas - Severe Hypertriglyceridemia | Phase 2 / Phase 3 | Completed | AstraZeneca | 399 | 2011-01-01 | 2016-08-04 |
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Hypertriglyceridemia (23) · Dyslipidemias (4) · Hyperlipidemias (4) · Metabolic Diseases (3) · Lipid Metabolism Disorders (2) · Atherosclerosis (1)
Nutritional and Metabolic Diseases (23) · Lipid Metabolism Disorders (21) · Metabolic Diseases (20) · Dyslipidemias (19) · Hyperlipidemias (19) · Arterial Occlusive Diseases (1) · Arteriosclerosis (1) · Cardiovascular Diseases (1) · Vascular Diseases (1)
olezarsen (4) · plozasiran (3) · Fenofibrate (2) · K-877 compound (2) · Omacor (2) · MAT9001 (1) · eicosapentaenoic acid ethyl ester (1) · gemcabene (1)
Ionis Pharmaceuticals, Inc. (5) · Arrowhead Pharmaceuticals (4) · AstraZeneca (3) · 89bio, Inc. (2) · Kowa Research Institute, Inc. (2) · Zhejiang Doer Biologics Co., Ltd. (2) · Eli Lilly and Company (1) · Matinas Biopharma, Inc (1) · NeuroBo Pharmaceuticals Inc. (1) · Sancilio and Company, Inc. (1) · Trygg Pharma, Inc. (1)
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Kevin C Maki, PhD (2) · Andrea L Lawless, MD (1) · Jianping Li (1) · Jianping Li, M.D. (1) · Judith Johnson (1) · Lee Golden, MD (1) · Linong Ji (1) · Michael H Davidson, MD, FACC (1) · Teresa Parli, MD (1)
PMID 40064331, PMID 41211918, PMID 23312053, PMID 24528690, PMID 32473640, PMID 37355760, PMID 38583092, PMID 38587249
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