Clinical trials: Severe Hypertriglyceridemia
Severe Hypertriglyceridemia (sHTG)
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.
- Trial name
- NCT03452228
- Testing
- evinacumab
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 52 people
- Sponsor
- Regeneron 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
Non Familial Chylocmicronemia Syndrome (Non-FCS)
A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.
- Trial name
- NCT01594983
- Testing
- LCQ908, Fenofibrate, Fish Oil
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 58 people
- Sponsor
- Novartis Pharmaceuticals
Hypertriglyceridemia
Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia
The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels.
- Trial name
- NCT01529424
- Testing
- ISIS apoC-III Rx
- Where
- 7 sites in United States, Canada
- Volunteers
- 89 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hypertriglyceridemia
Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia
This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL) hypertriglyceridemia.
- Trial name
- NCT02250105
- Testing
- ARI-3037MO
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Arisaph Pharmaceuticals Inc
Severe Hypertriglyceridemia
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
- Trial name
- NCT05681351
- Testing
- Olezarsen
- Where
- 262 sites in United States, Argentina and 31 more
- Volunteers
- 885 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
Cardiovascular, Metabolic Disease
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.
- Conditions
- Cardiovascular, Metabolic Disease, Dyslipidemias, Lipid Disorder
- Trial name
- NCT07491172
- Testing
- CTX310
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- CRISPR Therapeutics AG
Severe Hypertriglyceridemia (sHTG), Hypertriglyceridemia
A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG).
- Trial name
- NCT07693777
- Testing
- DR10624 Injection
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
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.
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
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
This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the…
- Trial name
- ECLIPSEIV (NCT02189252)
- Testing
- Epanova, Lovaza
- Where
- 4 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
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.
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
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
Severe Hypertriglyceridemia
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.
- Trial name
- NCT01229566
- Testing
- AKR-963
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Trygg Pharma, Inc.
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
Severe Hypertriglyceridemia
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
- Trial name
- NCT05079919
- Testing
- Olezarsen
- Where
- 209 sites in United States, Australia and 21 more
- Volunteers
- 617 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Severe Hypertriglyceridemia
A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus…
- Trial name
- NCT07680829
- Testing
- DR10624 Subcutaneous Injection, Icosapent Ethyl Oral Capsule
- Where
- 2 sites in China
- Volunteers
- 378 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
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.