Clinical trials: Severe Hypertriglyceridemia
Hypertriglyceridemia
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and…
- Trial name
- TRILOGY 1 (NCT03398005)
- Testing
- CaPre
- Where
- 69 sites in United States
- Volunteers
- 256 people
- Sponsor
- Grace Therapeutics Inc.
Severe Hypertriglyceridemia
The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)
The purpose of this study is to investigate the effects of SC401B (ethyl esters of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in…
- Trial name
- NCT01997268
- Testing
- SC401B 2 capsules, SC401B 4 capsules, SC401B 6 capsules
- Sponsor
- Sancilio and Company, 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.
Hypertriglyceridemia
Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides
The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo.
- Trial name
- OMEELVHT (NCT02625870)
- Testing
- Omega-3-Acid Ethyl Esters 90 Soft Capsules, Corn Oil
- Volunteers
- 240 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
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
Severe Hypertriglyceridemia
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat…
- Trial name
- ECLIPSE (NCT01208961)
- Testing
- Epanova (4 g) and Lovaza (4 g), Lovaza (4 g) and Epanova (4 g)
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Severe Hypertriglyceridemia, Mixed Dyslipidaemia
A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)
- Trial name
- INDIGO-1 (NCT02944383)
- Testing
- Gemcabene
- Where
- 49 sites in United States, Canada
- Volunteers
- 91 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Hyperlipoproteinemia
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
- Trial name
- NCT01146522
- Testing
- LCQ908
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Severe Hypertriglyceridemia
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
- Trial name
- NCT03011450
- Testing
- K-877, Fenofibrate
- Where
- 241 sites in United States, Belarus and 7 more
- Volunteers
- 471 people
- Sponsor
- Kowa Research Institute, Inc.
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.
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.
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
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 Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and <2000 mg/dL and normal renal function.
- Trial name
- NCT03001817
- Testing
- K-877, Fenofibrate
- Where
- 220 sites in United States, Belarus and 7 more
- Volunteers
- 551 people
- Sponsor
- Kowa Research Institute, Inc.
Hypertriglyceridemia
Efficacy of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia
The purpose of this study is to evaluate the efficacy and safety of ethyl icosapentate in Chinese patients with severe hypertriglyceridemia.
- Trial name
- NCT04239950
- Testing
- Ethyl Icosapentate
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Familial Chylomicronemia, High Risk Severe Hypertriglyceridemia (SHTG)
Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
This is a treatment program for the use of plozasiran in adults (AROAPOC3-EAP-002) and adolescents (AROAPOC3-EAP-003) with familial chylomicronemia syndrome (FCS) as well as in adults (AROAPOC3-EAP-004) with high risk severe…
- Trial name
- NCT06796426
- Testing
- Plozasiran
- Where
- United States
- Sponsor
- Arrowhead 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.