Clinical trials: Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with…
- Trial name
- LIBerate-FH (NCT04797104)
- Testing
- lerodalcibep
- Where
- 7 sites in United States, Israel and 3 more
- Volunteers
- 478 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia
A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
This was a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral lipid lowering treatment on top of a statin (Oral LLT cohort), newly…
- Trial name
- NCT05362903
- Testing
- Inclisiran
- Where
- 121 sites in Germany
- Volunteers
- 1,868 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Dyslipidemias
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
- Trial name
- PIVOTAL (NCT07083206)
- Where
- South Korea
- Volunteers
- 4,500 people
- Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
Homozygous Familial Hypercholesterolemia
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
This study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to <18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and…
- Trial name
- SPRUCE (NCT07473843)
- Testing
- Zodasiran
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 10 people
- Sponsor
- Arrowhead Pharmaceuticals
Heterozygous Familial Hypercholesterolemia (HeFH)
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
A phase 1/2, two-part trial consisting of an open label dose-escalation part and a randomized, double blind, placebo-controlled part to investigate safety, tolerability, pharmacokinetics, and efficacy with EDIT-401 gene editing…
- Trial name
- NCT07894887
- Testing
- Drug: EDIT-401
- Where
- 2 sites in Australia
- Volunteers
- 56 people
- Sponsor
- Editas Medicine, Inc.
Hypercholesterolemia, Hypertriglyceridemia
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia, Refractory Hyperlipidemia
- Trial name
- NCT06451770
- Testing
- VERVE-201
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 132 people
- Sponsor
- Verve Therapeutics, Inc.
Hyperlipidemia, Hypercholesterolemia
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood. Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to…
- Trial name
- NCT07821944
- Testing
- Enlicitide Decanoate
- Where
- India
- Volunteers
- 150 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).
- Trial name
- ASCEND-QW (NCT07477704)
- Testing
- Alirocumab
- Where
- 34 sites in United States
- Volunteers
- 438 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolaemia
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible…
- Trial name
- AKM Lab-01 (NCT06974266)
- Testing
- Probiotic
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.
Hypercholesterolemia, Lipid Metabolism Disorders
Metabolic Effects of an Ophiocordyceps Sinensis- and CoQ10-Based Formulation in Mild-to-Moderate Hypercholesterolemia
This randomized, double-blind, placebo-controlled study will evaluate the metabolic effects of CORDICOL, a formulation containing Ophiocordyceps sinensis extract (200 mg) and Coenzyme Q10 (50 mg), in adults with mild-to-moderate…
- Conditions
- Hypercholesterolemia, Lipid Metabolism Disorders, Lipid Metabolism, Nutraceutical
- Trial name
- CORDICOL (NCT07852481)
- Testing
- CORDICOL
- Volunteers
- 140 people
- Sponsor
- noiVita Srls
Hyperlipidemia (E.G., Hypercholesterolemia)
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
The goal of this clinical trial is to evaluate the efficacy and safety of a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy in the Bangladeshi population.
- Trial name
- NCT06789432
- Testing
- Atorvastatin 10 mg and ezetimibe 10 mg, Atorvastatin 20 mg
- Where
- Bangladesh
- Sponsor
- Dr. Md. Alimur Reza
Heterozygous Familial Hypercholesterolemia (HeFH)
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol…
- Trial name
- NCT07058077
- Testing
- Enlicitide Decanoate
- Where
- 47 sites in United States, Australia and 17 more
- Volunteers
- 153 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolaemia
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in…
- Trial name
- NCT07619118
- Testing
- laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2, laroprovstat/rosuvastatin 3
- Where
- 45 sites in United States, Australia and 2 more
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Hypercholesterolemia, Mixed Dyslipidemia
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic…
- Trial name
- MILOS (NCT04579367)
- Testing
- Bempedoic acid and/or its fixed-dose combination with ezetimibe
- Where
- 443 sites in Austria, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment…
- Trial name
- NCT05934292
- Testing
- Enlicitide Decanoate
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Atherosclerosis, Mixed Dyslipidemia
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and…
- Conditions
- Coronary Atherosclerosis, Mixed Dyslipidemia, Hypercholesterolemia
- Trial name
- NCT07474649
- Testing
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 103 people
- Sponsor
- Daiichi Sankyo
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical…
- Trial name
- VICTORION REAL (NCT05399992)
- Testing
- Inclisiran
- Where
- 38 sites in Austria, China and 6 more
- Volunteers
- 847 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia.
- Trial name
- NCT05952856
- Testing
- Enlicitide Decanoate
- Where
- 168 sites in United States, Argentina and 12 more
- Volunteers
- 2,912 people
- Sponsor
- Merck Sharp & Dohme LLC
Atherosclerosis, Cardiovascular Disease
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.
- Conditions
- Atherosclerosis, Cardiovascular Disease, Hypercholesterolemia
- Trial name
- HEART-3 (NCT07839936)
- Testing
- VERVE-102
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Verve Therapeutics, Inc.
Coronary Artery Disease, Hypercholesterolemia
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled…
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
- Trial name
- NCT07803679
- Testing
- Evolocumab, Routine Lipid Management, Autoinjector
- Volunteers
- 308 people
- Sponsor
- Amgen