Clinical trials: Elevated LDL-C
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidemias, Hypercholesterolemia
Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia, High LDL-C
- Trial name
- REMAINS (NCT01245738)
- Volunteers
- 635 people
- Sponsor
- Merck Sharp & Dohme LLC
Hyperlipoproteinemia(a), Progressive Cardiovascular Disease
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)
Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular disease. Non-medical treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma concentrations.
- Trial name
- ELAILa (NCT01064934)
- Testing
- Lipid apheresis, Standard care
- Where
- Germany
- Sponsor
- Charite University, Berlin, Germany
ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment…
- Conditions
- ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction, LDL-cholesterol
- Trial name
- GoT (NCT05587621)
- Testing
- statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran
- Where
- 10 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Jena University Hospital
Hypercholesterolemia
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Trial name
- NCT03051100
- Testing
- Bempedoic acid 180mg, Ezetimibe 10mg, Atorvastatin 20mg
- Where
- 11 sites in United States
- Volunteers
- 63 people
- Sponsor
- Esperion Therapeutics, Inc.
ASCVD
Improving Implementation of Guideline-Recommended LDL-C Management in High-Risk Cardiovascular Patients
The goal of this observational study is to learn whether implementing evidence-based strategies in cardiology practices can improve guideline-recommended low-density lipoprotein cholesterol (LDL-C) management in adults at high…
- Trial name
- EMPOWER (NCT07883564)
- Where
- 5 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Cardiology Consultants of Philadelphia
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.
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with…
- Trial name
- ORION-15 (NCT04666298)
- Testing
- Inclisiran sodium
- Where
- 42 sites in Japan
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
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
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Dyslipidemia
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.
The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination…
- Trial name
- NCT05787002
- Testing
- AZD0780, Rosuvastatin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
To Reduce the LDL-C Level in Hypercholesteremia Adult Patients, Combination for Subgroup High LDL-c Patients With Other Comorbidities
Adult Subjects With Elevated Low-Density Lipoprotein-Cholesterol to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects
Objectives: The primary and secondary objectives of the study are presented below. Exploratory objectives are presented in the body of the protocol.
- Trial name
- NCT05905068
- Testing
- RN0191 INJECTION
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ikaria Bioscience Pty Ltd
Hypercholesterolemia, Cardiovascular Diseases
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
Comparison of LDL-C reductions at Week 12 of monthly (Q4W[≤ 31 days]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or…
- Trial name
- LIBerate-H2H (NCT04790513)
- Testing
- lerodalcibep, evolocumab, alirocumab
- Where
- 3 sites in United States
- Volunteers
- 204 people
- Sponsor
- LIB Therapeutics LLC
ASCVD, LDL-C
Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?
The goal of this implementation trial is to learn if providing education to doctors and patients who have had a heart event works to prevent future heart problems. The main questions it aims to answer are: 1.
- Trial name
- T2T (NCT06471036)
- Testing
- Care Champion Intervention
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Duke University
Diabetes Mellitus, Macular Edema
Laser and Medical Treatment of Diabetic Macular Edema
This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes.
- Trial name
- NCT00027287
- Testing
- Vitamin E
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National Eye Institute (NEI)
Hypercholesterolemia, Mixed Dyslipidemia
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2…
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Trial name
- BANTING (NCT02739984)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 424 people
- Sponsor
- Amgen
Healthy Volunteers
A Clinical Study for Evaluating the Safety of a Plant Sterol-enriched Fermented Dairy Product in Japanese Healthy Adults
Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults
- Trial name
- NCT02278393
- Testing
- 1-Fermented Dairy Product with Phytosterols (test), 2-Fermented dairy Product with No Phytosterols (control)
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Danone Japan
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
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
Hyperlipidemia
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with…
- Trial name
- ORION-14 (NCT04774003)
- Testing
- 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran), 300 mg inclisiran sodium (equivalent to 284 mg inclisiran)
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals