A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia, Familial Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT05952869
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 303
- Starts
- 2023-08-08
- Expected to finish
- 2025-04-07
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
- Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
- Is treated with a moderate- or high-intensity statin medication
- Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
You may not qualify if…
- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
- Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
- Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
- Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
Where it is running
- Excel Medical Clinical Trials ( Site 0008) — Boca Raton, Florida, United States
- Advanced Pharma Research ( Site 0007) — Cutler Bay, Florida, United States
- Progressive Medical Research ( Site 0021) — Port Orange, Florida, United States
- Clinical Site Partners LLC, dba CSP Orlando ( Site 0028) — Winter Park, Florida, United States
- Synexus Clinical Research US - Evansville ( Site 0031) — Evansville, Indiana, United States
- Franciscan Physician Network - Indiana Heart Physicians ( Site 0040) — Indianapolis, Indiana, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001) — Troy, Michigan, United States
- Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026) — Lincoln, Nebraska, United States
- Jubilee Clinical Research ( Site 0030) — Las Vegas, Nevada, United States
- Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041) — Winston-Salem, North Carolina, United States
- Velocity Clinical Research, Salt Lake City ( Site 0004) — West Jordan, Utah, United States
- Health Research of Hampton Roads, Inc. ( Site 0020) — Newport News, Virginia, United States
- Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808) — Camperdown, New South Wales, Australia
- Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803) — Clayton, Victoria, Australia
- Universidade Federal Do Ceara ( Site 0702) — Fortaleza, Ceará, Brazil
- Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701) — São Paulo, São Paulo, Brazil
- Incor - Instituto do Coracao ( Site 0703) — São Paulo, Brazil
- Ecogene-21 ( Site 0510) — Chicoutimi, Quebec, Canada
- Institut de Cardiologie de Montreal ( Site 0506) — Montreal, Quebec, Canada
- Diex Recherche Trois-Rivieres ( Site 0513) — Trois-Rivières, Quebec, Canada
- Clinical Research Chile SpA ( Site 0804) — Valdivia, Los Ríos Region, Chile
- CDIEM ( Site 0814) — Providencia, Region M. de Santiago, Chile
- Enroll SpA ( Site 0803) — Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile-CICUC ( Site 0812) — Santiago, Region M. de Santiago, Chile
- Alliance for Multispecialty Research, LLC ( Site 0023) — Daphne, Alabama, United States
Full record on ClinicalTrials.gov
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