229 completed, 22 terminated, 9 recruiting, 5 active not recruiting. 275 Phase 3, 9 Phase 2.
Follow Hypercholesterolemia: new trials by email Literature Review of Hypercholesterolemia trials Research Report on Hypercholesterolemia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on LDL-C in LLT-naïve Patients Laroprovstat, Rosuvastatin 1, Rosuvastatin 2 - Hypercholesterolemia | Phase 3 | Not yet recruiting | AstraZeneca | 204 | 2026-12-21 | 2026-11-12 |
| A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038) Enlicitide Decanoate, Placebo - Hyperlipidemia, Hypercholesterolemia | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 150 | 2026-10-15 | 2026-11-02 |
| A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events Bempedoic acid, Ezetimibe, Rosuvastatin - Coronary Atherosclerosis, Mixed Dyslipidemia | Phase 3 | Not yet recruiting | Daiichi Sankyo | 103 | 2026-09-30 | 2026-09-29 |
| A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2, laroprovstat/rosuvastatin 3 - Hypercholesterolaemia | Phase 3 | Recruiting | AstraZeneca | 200 | 2026-09-10 | 2026-10-05 |
| A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients. Laroprovstat, Rosuvastatin 1, Rosuvastatin 2 - Hypercholesterolaemia | Phase 3 | Recruiting | AstraZeneca | 600 | 2026-08-12 | 2026-09-10 |
| Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH lerodalcibep 300 mg Monthly SC - Familial Hypercholesterolemia - Heterozygous | Phase 3 | Enrolling by invitation | LIB Therapeutics LLC | 150 | 2026-07-20 | 2026-07-28 |
| Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days Obicetrapib 10 mg/Bempedoic Acid Placebo, Bempedoic Acid 180mg/Placebo Obicetrapib - Mixed Dyslipidemia, Hypercholesterolaemia | Phase 3 | Recruiting | A. Menarini International Licensing S.A. | 426 | 2026-05-06 | 2026-06-09 |
| A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors SHR-1918 Injection, SHR-1918 Injection Placebo - Hypercholesterolemia | Phase 2 / Phase 3 | Recruiting | Beijing Suncadia Pharmaceuticals Co., Ltd | 126 | 2026-04-30 | 2026-06-16 |
| Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia Inclisiran, Placebo - Familial Hypercholesterolemia - Homozygous | Phase 3 | Recruiting | Novartis Pharmaceuticals | 9 | 2025-02-28 | 2026-07-24 |
| Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia Inclisiran, Placebo - Familial Hypercholesterolemia - Heterozygous | Phase 3 | Recruiting | Novartis Pharmaceuticals | 60 | 2024-12-09 | 2026-05-15 |
| A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia Lerodalcibep, matching placebo - Hypercholesterolemia, Dyslipidemias | Phase 3 | Recruiting | Hasten Biopharmaceutical Co., Ltd. | 210 | 2024-11-16 | 2025-02-06 |
| A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R AG2304T, AG2304R - Hypercholesterolemia | Phase 3 | Completed | Ahn-Gook Pharmaceuticals Co.,Ltd | 158 | 2024-09-30 | 2026-06-18 |
| Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension Enlicitide Decanoate - Hypercholesterolemia | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 3000 | 2024-08-05 | 2025-10-07 |
| A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) Enlicitide, Ezetimibe, Bempedoic Acid - Hypercholesterolemia | Phase 3 | Completed | Merck Sharp & Dohme LLC | 301 | 2024-07-08 | 2026-03-27 |
| Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women Phytoestrogen, Diet control & life style modification - Dyslipidemias, Hypertriglyceridemia | Phase 2 / Phase 3 | Unknown | Dhurakij Pundit University | 10 | 2024-03-02 | 2024-05-24 |
| Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe - Dyslipidemias, Hypercholesterolemia | Phase 3 | Completed | NewAmsterdam Pharma | 407 | 2024-03-01 | 2025-10-08 |
| A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia SAL003 140 mg, Placebo - Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia | Phase 3 | Completed | Shenzhen Salubris Pharmaceuticals Co., Ltd. | 720 | 2023-12-19 | 2025-11-28 |
| Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes Enlicitide Decanoate, Placebo - Arteriosclerosis, Hypercholesterolaemia | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 14550 | 2023-10-09 | 2026-04-23 |
| A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids Enlicitide Decanoate, Placebo - Hypercholesterolemia, Familial Hypercholesterolemia | Phase 3 | Completed | Merck Sharp & Dohme LLC | 2912 | 2023-08-10 | 2026-09-24 |
| A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH) Enlicitide Decanoate, Placebo - Hypercholesterolemia, Familial Hypercholesterolemia | Phase 3 | Completed | Merck Sharp & Dohme LLC | 303 | 2023-08-08 | 2026-02-24 |
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Dyslipidemias (47) · Hyperlipidemias (47) · Hyperlipoproteinemia Type II (26) · Atherosclerosis (23) · Coronary Disease (20) · Cardiovascular Diseases (17) · Hypertension (16) · Diabetes Mellitus (10) · Homozygous Familial Hypercholesterolemia (9) · Diabetes Mellitus, Type 2 (6) · Hypertriglyceridemia (6) · Metabolic Diseases (6) · Stroke (6) · Coronary Artery Disease (5)
Nutritional and Metabolic Diseases (275) · Lipid Metabolism Disorders (271) · Metabolic Diseases (269) · Dyslipidemias (228) · Hyperlipidemias (228) · Vascular Diseases (59) · Cardiovascular Diseases (51) · Arterial Occlusive Diseases (29) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (28) · Heart Diseases (28) · Arteriosclerosis (27) · Metabolism, Inborn Errors (26) · Myocardial Ischemia (26) · Hyperlipoproteinemias (25) · Lipid Metabolism, Inborn Errors (25)
Ezetimibe (81) · Atorvastatin (62) · Rosuvastatin Calcium (47) · Simvastatin (46) · evolocumab (26) · alirocumab (23) · 1-((1-(3-acetoxy-2,2-dimethylpropyl)-7-chloro-5-(2,3-dimethoxyphenyl)-2-oxo-1,2,3,5-tetrahydro-4,1-benzoxazepin-3-yl)acetyl)piperidine-4-acetic acid (12) · Ezetimibe, Simvastatin Drug Combination (11) · 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (9) · ALN-PCS (9) · Pravastatin (8) · pitavastatin (8) · Duration of Therapy (6) · MK-0616 (6) · Niacin (6)
Organon and Co (56) · AstraZeneca (25) · Amgen (24) · Sanofi (22) · Merck Sharp & Dohme LLC (15) · Takeda (12) · Novartis Pharmaceuticals (10) · Kowa Research Europe (7) · Esperion Therapeutics, Inc. (6) · LIB Therapeutics LLC (6) · Kastle Therapeutics, LLC (5) · National Heart, Lung, and Blood Institute (NHLBI) (5) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (5) · Novartis (4) · Regeneron Pharmaceuticals (4)
United States (106) · Canada (60) · Netherlands (49) · Spain (47) · United Kingdom (47) · Germany (43) · South Africa (43) · Czechia (36) · France (35) · Italy (33) · Denmark (32) · Israel (32) · Hungary (30) · Norway (30) · Poland (30)
Russell Esterline (8) · Ron Haberman, MD (5) · Dragos Budinski, Med Dr. (4) · Dragos Budinski, MD (3) · Evan A Stein, MD PhD (3) · Masayasu Matsumoto, MD, PhD (3) · Hyo Soo Kim, M.D., Ph.D (2)
PMID 33078867, PMID 21518985, PMID 27777279, PMID 30183102, PMID 34298554, PMID 28964736, PMID 32609313, PMID 35916348, PMID 25614280, PMID 27578134, PMID 28391886, PMID 38063346, PMID 38757725, PMID 41604274, PMID 22087637, PMID 24014831, PMID 25269777, PMID 25431239, PMID 32187462, PMID 37282500, PMID 37565307, PMID 41903707, PMID 12719279, PMID 15311720, PMID 15389231, PMID 16034009, PMID 16651474, PMID 16705107, PMID 17167114, PMID 17325296, PMID 17355745, PMID 17384434, PMID 17533211, PMID 17617940, PMID 17846352, PMID 17985033, PMID 17987126, PMID 18000186, PMID 18196620, PMID 18227370, PMID 18376000, PMID 18376001, PMID 18422390, PMID 18539917, PMID 18676075, PMID 18702965, PMID 18765432, PMID 18940534, PMID 19001024, PMID 19014834
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