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NCT05952869 · ClinicalTrials.gov registry record · Phase 3
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
A Phase 3 study of Hypercholesterolemia and Familial Hypercholesterolemia, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 303
- Enrollment target
- 20
- Study locations
NCT05952869: Completed Phase 3 study of Hypercholesterolemia and Familial Hypercholesterolemia, sponsored by Merck Sharp & Dohme.
NCT05952869 is a Phase 3 study of Hypercholesterolemia and Familial Hypercholesterolemia that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 303 participants, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05952869, a Phase 3 study of Hypercholesterolemia and Familial Hypercholesterolemia, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 303 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Blood samples were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Enlicitide Decanoate
Study Locations (20)
Florida
- Excel Medical Clinical Trials ( Site 0008) - Boca Raton
- Advanced Pharma Research ( Site 0007) - Cutler Bay
- Progressive Medical Research ( Site 0021) - Port Orange
- Clinical Site Partners LLC, dba CSP Orlando ( Site 0028) - Winter Park
Indiana
- Synexus Clinical Research US - Evansville ( Site 0031) - Evansville
- Franciscan Physician Network - Indiana Heart Physicians ( Site 0040) - Indianapolis
Quebec
- Ecogene-21 ( Site 0510) - Chicoutimi
- Institut de Cardiologie de Montreal ( Site 0506) - Montreal
Alabama
- Alliance for Multispecialty Research, LLC ( Site 0023) - Daphne
Michigan
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001) - Troy
Nebraska
- Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026) - Lincoln
Nevada
- Jubilee Clinical Research ( Site 0030) - Las Vegas
North Carolina
- Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041) - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2025-04-07 |
| Phase | Phase 3 |
What the finished NCT05952869 record still lists
NCT05952869 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05952869 names 20 study sites across 15 states, led by Florida, Indiana, Quebec.
Frequently Asked Questions
What is clinical trial NCT05952869 about?
NCT05952869 is a clinical study titled "A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)". 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 l...
What is the current status of trial NCT05952869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2023-08-08. Estimated completion is 2025-04-07.
What conditions does trial NCT05952869 study?
This clinical trial studies the following conditions: Hypercholesterolemia, Familial Hypercholesterolemia.
What interventions are being tested in trial NCT05952869?
The interventions under investigation include: Placebo (DRUG), Enlicitide Decanoate (DRUG).
Who is sponsoring clinical trial NCT05952869?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05952869 being conducted?
This trial has 20 study locations across Alabama, Florida, Indiana, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypercholesterolemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05952869's enrollment target sits among peer trials
303 26th of 62 higher than 37 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
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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 (MK-0616-018) CORALreef AddOn
COMPLETED · Phase 3
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