Clinical trials: LDL-C
Healthy Volunteer
Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of orally administered lomitapide in healthy male Japanese and Caucasian subjects with elevated LDL-C.
- Trial name
- NCT01760187
- Testing
- lomitapide
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Coronary Disease
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)
This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100 mg/dL in patients at risk for Heart…
- Trial name
- NCT00551447
- Testing
- MK0653, ezetimibe / Duration of Treatment: 27 Weeks, MK0733, simvastatin / Duration of Treatment: 27 Weeks, Comparator: simvastatin / Duration of Treatment: 27 Weeks
- Volunteers
- 616 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
- Trial name
- NCT01849497
- Testing
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- Where
- 26 sites in United States, Canada
- Volunteers
- 149 people
- Sponsor
- Amgen
Dyslipidemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10582 following single and multiple dose administration to healthy subjects and subjects with Mildly Elevated LDL-C.
- Trial name
- NCT07777003
- Testing
- HS-10582
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hypercholesterolemia, Healthy Volunteers
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated…
- Conditions
- Hypercholesterolemia, Healthy Volunteers, LDL-Cholesterol
- Trial name
- NCT06504043
- Testing
- HST101
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hasten Biopharmaceutical Co., Ltd.
Hypercholesterolemia
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.
- Trial name
- NCT01600820
- Testing
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit, 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit, 3- Low fat drinkable fermented dairy product without plant sterols(control)
- Where
- Spain
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Danone Spain
Diabetes Mellitus Type 2, Crestor, Rosuvastatin
DIALOOG: Crestor in Patients With Diabetes Mellitus Type 2: Lowering of LDL-C Levels to New European Guidelines
The purpose of this study is to determine in DM II patients the efficacy of Crestor in obtaining the new European LDL cholesterol guidelines.
- Conditions
- Diabetes Mellitus Type 2, Crestor, Rosuvastatin, LDL Cholesterol, Observational
- Trial name
- NCT00233649
- Where
- 222 sites in Netherlands
- Volunteers
- 2,500 people
- Sponsor
- AstraZeneca
Primary Hypercholesterolemia or Mixed Hyperlipidemia
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering…
- Trial name
- NCT07441317
- Testing
- QLC7401
- Volunteers
- 780 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesterolemia
Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
The objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required
- Trial name
- CANACTFAST (NCT00150371)
- Testing
- atorvastatin
- Where
- 84 sites in Canada
- Volunteers
- 1,100 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Dyslipidaemia
Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia
The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/ the 4th Joint…
- Trial name
- CEPHEUS (NCT01221584)
- Where
- 8 sites in Russia
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD…
- Conditions
- Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
- Trial name
- LIBerate-OLE (NCT04798430)
- Testing
- lerodalcibep
- Where
- 12 sites in United States, India and 4 more
- Volunteers
- 2,000 people
- Sponsor
- LIB Therapeutics LLC
Healthy, NAFLD
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
- Conditions
- Healthy, NAFLD, Hyperlipidemia
- Trial name
- NCT04692025
- Testing
- ASC41 tablet
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gannex Pharma Co., Ltd.
Cardiovascular Risk Factor, Cardiovascular Diseases
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a…
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Cardiovascular Stroke, Hypercholesterolemia
- Trial name
- LIBerate-HR (NCT04806893)
- Testing
- lerodalcibep
- Where
- 6 sites in United States, India and 1 more
- Volunteers
- 900 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia, Atherosclerotic Ischemic Disease
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
- Trial name
- LIBerate-VI (NCT05004675)
- Testing
- lerodalcibep, Inclisiran
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 166 people
- Sponsor
- LIB Therapeutics LLC
Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran.
- Trial name
- ORION-9 (NCT03397121)
- Testing
- Inclisiran
- Where
- 45 sites in United States, Canada and 6 more
- Volunteers
- 482 people
- Sponsor
- The Medicines Company
Dyslipidemias
Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
- Trial name
- NCT04829149
- Testing
- Observational
- Where
- South Korea
- Volunteers
- 5,717 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidemia, Hypercholesterolemia
A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be…
- Trial name
- NCT01333436
- Testing
- Test Meal
- Where
- South Korea
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.