| enlicitide decanoate (MK-0616) / Merck (MSD), UCB |
MK-0616-018, NCT06450366: A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia () CORALreef AddOn |
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| Recruiting | 3 | 300 | Europe, Canada, US, RoW | Enlicitide Decanoate, MK-0616, Ezetimibe, Bempedoic Acid, Placebo for Enlicitide Decanoate, Placebo for Ezetimibe, Placebo for Bempedoic Acid | Merck Sharp & Dohme LLC | Hypercholesterolemia | 07/25 | 09/25 | | |
MK-0616-019, NCT06492291: Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia () CORALreef Extension |
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| Recruiting | 3 | 3000 | Europe, Canada, Japan, US, RoW | Enlicitide Decanoate, MK-0616, Enlicitide | Merck Sharp & Dohme LLC | Hypercholesterolemia | 10/28 | 10/28 | | |
MK-0616-013, NCT05952856: A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia () CORALreef Lipids |
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| Active, not recruiting | 3 | 2760 | Europe, Japan, US, RoW | Enlicitide Decanoate, MK-0616, Placebo | Merck Sharp & Dohme LLC | Hypercholesterolemia, Familial Hypercholesterolemia | 08/25 | 08/25 | | |
MK-0616-017, NCT05952869: A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia () CORALreef HeFH |
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| Active, not recruiting | 3 | 270 | Europe, Canada, US, RoW | Enlicitide Decanoate, MK-0616, Placebo | Merck Sharp & Dohme LLC | Hypercholesterolemia, Familial Hypercholesterolemia | 04/25 | 04/25 | | |
MK-0616-015, NCT06008756: Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study () CORALreef Outcomes |
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| Recruiting | 3 | 14550 | Europe, Canada, Japan, US, RoW | Enlicitide Decanoate, MK-0616, Placebo | Merck Sharp & Dohme LLC | Arteriosclerosis, Hypercholesterolaemia | 11/29 | 11/29 | | |
2021-005221-24: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia |
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| Not yet recruiting | 2 | 375 | Europe | MK-0616, Capsule | Merck Sharp & Dohme LLC, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Merck Sharp & Dohme LLC, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Hypercholesterolemia, High Cholesterol, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
| Completed | 1 | 56 | US | Enlicitide Chloride, MK-0616, Placebo | Merck Sharp & Dohme LLC | Healthy, Hypercholesterolemia | 01/24 | 01/24 | | |
| Completed | 1 | 24 | US | MK-0616 | Merck Sharp & Dohme LLC | Hypercholesterolemia | 12/22 | 12/22 | | |
NCT06658626: A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016) |
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| Completed | 1 | 8 | US | [¹⁴C]Enlicitide chloride, MK-0616 | Merck Sharp & Dohme LLC | Healthy | 08/23 | 08/23 | | |
MK-0616-007, NCT05070390: A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment |
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| Completed | 1 | 18 | US | Enlicitide Chloride, MK-0616 | Merck Sharp & Dohme LLC | Moderate Renal Impairment | 05/23 | 05/23 | | |
MK-0616-022, NCT06658652: The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) |
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| Completed | 1 | 34 | US | Enlicitide decanoate, MK-0616 | Merck Sharp & Dohme LLC | Healthy | 12/23 | 12/23 | | |
| Completed | 1 | 33 | US | Enlicitide Decanoate, MK-0616 | Merck Sharp & Dohme LLC | Hypercholesterolaemia | 01/24 | 01/24 | | |
| Completed | 1 | 28 | US | Levothyroxine, Synthroid, Enlicitide Decanoate, MK-0616 | Merck Sharp & Dohme LLC, Celerion | Healthy | 08/24 | 09/24 | | |
| Recruiting | 1 | 40 | US | Enlicitide, enlicitide decanoate, MK-0616/sodium caprate | Merck Sharp & Dohme LLC | Hepatic Insufficiency, Hepatic Impairment | 03/25 | 03/25 | | |
NCT06597760: A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) |
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| Active, not recruiting | 1 | 24 | US | Enlicitide, enlicitide decanoate, MK-0616/sodium caprate, Digoxin | Merck Sharp & Dohme LLC, Celerion | Healthy | 11/24 | 11/24 | | |
NCT06609512: A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) |
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| Recruiting | 1 | 20 | US | Enlicitide, MK-0616, enlicitide decanoate | Merck Sharp & Dohme LLC | Healthy | 01/25 | 01/25 | | |
| Not yet recruiting | 1 | 24 | NA | Enlicitide, Enlicitide decanoate, MK-0616 | Merck Sharp & Dohme LLC | Healthy, Renal Impairment | 05/25 | 05/25 | | |
