Clinical trials: Lipoprotein Metabolism Disorder
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
ASCVD, Elevated Cholesterol
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability…
- Trial name
- ORION-10 (NCT03399370)
- Testing
- Inclisiran Sodium
- Where
- 145 sites in United States
- Volunteers
- 1,561 people
- Sponsor
- The Medicines Company
Hypercholesterolemia, Dyslipidaemia
Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.
- Trial name
- ARIES (NCT00653744)
- Testing
- Rosuvastatin, Atorvastatin
- Volunteers
- 1,700 people
- Sponsor
- AstraZeneca
Dyslipidaemias, Dyslipidaemia
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving…
- Trial name
- NCT00158899
- Testing
- GW501516 oral tablets
- Where
- 64 sites in Belgium, Denmark and 9 more
- Volunteers
- 424 people
- Sponsor
- GlaxoSmithKline
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST (NCT00442845)
- Testing
- Atorvastatin (Lipitor)
- Where
- 121 sites in Cameroon, Canada and 3 more
- Volunteers
- 2,080 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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 and Mixed Dyslipidemia
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable…
- Trial name
- NCT07278830
- Testing
- SAL003 140mg+Atorvastatin, SAL003 420mg+Atorvastatin
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Hypercholesterolemia
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
To evaluate the effects of daily consumption of 3 capsules of Swisse Nutra+ Cholesterol Balance on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months.
- Trial name
- CLoNE (NCT04783714)
- Testing
- Swisse Nutra+ Cholesterol Balance
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Swisse Wellness Pty Ltd
Hyperlipidemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0167 in Healthy Participants
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAL0167 following single and multiple dose administration in healthy participants.
- Trial name
- NCT07722299
- Testing
- SAL0167 group
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
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
Fredrickson Type IIa & Type IIb Dyslipidaemia
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia
- Trial name
- NCT00654446
- Testing
- Rosuvastatin, Simvastatin
- Volunteers
- 442 people
- Sponsor
- AstraZeneca
Hypercholesterolemia, Hyperlipidemias
Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester
The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate…
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Trial name
- NCT03284918
- Testing
- Plant stanol ester
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Raisio Group
Hypercholesterolemia
Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects
Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel group, phase I clinical trial of repeated administration by subcutaneous injection of a single dose of one of two different proprotein…
- Trial name
- AFF012 (NCT02508896)
- Testing
- AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant, Adjuvant without active component
- Where
- Austria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Affiris AG
Metabolic Syndrome X
ROMEO (Rosuvastatin in Metabolic syndrOme)
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.
- Trial name
- NCT00395486
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 3 sites in South Korea
- Volunteers
- 258 people
- Sponsor
- AstraZeneca
Primary Hypercholesterolemia or Mixed Dyslipidemia
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein…
- Trial name
- V-Mono China (NCT05888103)
- Testing
- Inclisiran
- Where
- 28 sites in China
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals