Clinical trials: Severe Hypertriglyceridemia
Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease
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
The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in…
- Conditions
- Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia
- Trial name
- NCT05355402
- Testing
- Olezarsen
- Where
- 24 sites in United States, Canada
- Volunteers
- 154 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Familial Chylomicronemia Syndrome (FCS)
CS-121 APOC3 Base Editing in FCS
This is an open-label, single-arm, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of CS-121, an in vivo base editing therapy delivered by lipid…
- Trial name
- NCT07176923
- Testing
- CS-121
- Where
- China
- Volunteers
- 15 people
- Sponsor
- CorrectSequence Therapeutics Co., Ltd
Severe Hypertriglyceridemia
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.
- Trial name
- ENTRUST (NCT05852431)
- Testing
- Pegozafermin
- Where
- 177 sites in United States, Argentina and 18 more
- Volunteers
- 369 people
- Sponsor
- 89bio, Inc.
Hypertriglyceridemia
A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)
The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L)…
- Trial name
- TRILOGY 2 (NCT03361501)
- Testing
- CaPre
- Where
- 68 sites in United States, Canada and 1 more
- Volunteers
- 278 people
- Sponsor
- Grace Therapeutics Inc.
Hypertriglyceridemia, Severe Hypertriglyceridemia
A Study to Assess the Safety, Tolerability and Efficacy of ION775
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).
- Trial name
- NCT07604974
- Testing
- ION775
- Where
- 17 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Severe Hypertriglyceridemia
Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly [QW] or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in…
- Trial name
- NCT04541186
- Testing
- Pegozafermin
- Where
- 48 sites in United States, Czechia and 2 more
- Volunteers
- 86 people
- Sponsor
- 89bio, Inc.
Severe Hypertriglyceridemia
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
- Trial name
- NCT05552326
- Testing
- Olezarsen
- Where
- 205 sites in United States, Argentina and 21 more
- Volunteers
- 446 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hypertriglyceridemia, Familial Chylomicronemia
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and…
- Trial name
- NCT03783377
- Testing
- ARO-APOC3, sterile normal saline (0.9% NaCl)
- Where
- 10 sites in Australia, Canada and 1 more
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Hypertriglyceridemia
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
The primary objective of the study is to determine the proportion of patients with elevated triglycerides (TG), without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL)…
- Trial name
- NCT04863014
- Testing
- evinacumab
- Where
- 39 sites in United States, Canada and 2 more
- Volunteers
- 21 people
- Sponsor
- Regeneron Pharmaceuticals
Pediatric Homozygous Familial Hypercholesterolemia (HoFH), Severe Hypertriglyceridemia (HTG)
Compassionate Use of Evinacumab
Provide compassionate use of evinacumab
- Conditions
- Pediatric Homozygous Familial Hypercholesterolemia (HoFH), Severe Hypertriglyceridemia (HTG), Dysbetalipoproteinemia (DBL)
- Trial name
- NCT06500598
- Testing
- Evinacumab
- Sponsor
- Regeneron Pharmaceuticals
Hyperlipidemias, Hypertriglyceridemia
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy.
- Conditions
- Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders
- Trial name
- NCT01968720
- Testing
- CAT-2003
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Catabasis Pharmaceuticals
Severe Hypertriglyceridemia
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in participants with severe hypertriglyceridemia.
- Trial name
- SOLARIS-1 (NCT07269210)
- Testing
- Solbinsiran
- Where
- 41 sites in United States, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Eli Lilly and Company
Hypertriglyceridemia
Epanova® for Lowering Very High Triglycerides II (EVOLVE II)
This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia.
- Trial name
- EVOLVEII (NCT02009865)
- Testing
- Epanova, Olive Oil
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 379 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Non-Insulin-Dependent, Hypertriglyceridemia
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and…
- Trial name
- NCT02113163
- Testing
- Metformin Eicosapentaenoate, Metformin HCl and Vascepa
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Thetis Pharmaceuticals LLC
Severe Hypertriglyceridemia
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG).
- Trial name
- SHASTA-4 (NCT06347016)
- Testing
- Plozasiran Injection
- Where
- 149 sites in United States, Argentina and 14 more
- Volunteers
- 311 people
- Sponsor
- Arrowhead Pharmaceuticals
Severe Hypertriglyceridemia
Epanova® for Lowering Very High Triglycerides
The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.
- Trial name
- EVOLVE (NCT01242527)
- Testing
- omefas
- Where
- 68 sites in United States, Denmark and 5 more
- Volunteers
- 399 people
- Sponsor
- AstraZeneca
Severe Hypertriglyceridemia
A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities.
- Trial name
- NCT06555640
- Testing
- DR10624 Injection
- Where
- 35 sites in China
- Volunteers
- 79 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
Severe Hypertriglyceridemia
Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL
To determine the efficacy of MAT9001 compared to placebo in lowering fasting triglyceride levels in subjects with very high fasting triglyceride levels ≥ 500 and < 2000 mg/dL.
- Trial name
- AMPLIFY (NCT04662528)
- Testing
- MAT9001 (omega-3 pentaenoic acid)
- Sponsor
- Matinas Biopharma, Inc
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial evaluating the efficacy and safety of FXR0906 in patients with severe hypertriglyceridemia or hypertriglyceridemia with atherosclerotic…
- Trial name
- NCT07889245
- Testing
- FXR0906 injection
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.
Severe Hypertriglyceridemia
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to…
- Trial name
- SHASTA-5 (NCT06880770)
- Testing
- Plozasiran
- Where
- 140 sites in United States, Argentina and 25 more
- Volunteers
- 288 people
- Sponsor
- Arrowhead Pharmaceuticals