Trials / Completed
CompletedNCT05952869
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 303 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enlicitide Decanoate | Oral tablet |
| DRUG | Placebo | Oral tablet (placebo). |
Timeline
- Start date
- 2023-08-08
- Primary completion
- 2025-04-07
- Completion
- 2025-04-07
- First posted
- 2023-07-19
- Last updated
- 2026-02-24
- Results posted
- 2026-02-24
Locations
59 sites across 17 countries: United States, Australia, Brazil, Canada, Chile, Colombia, Czechia, Finland, Hong Kong, Hungary, Israel, Netherlands, New Zealand, Norway, Singapore, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05952869. Inclusion in this directory is not an endorsement.