A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05952869
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Aug 8, 2023
Status verified
Feb 2026
Primary completion
Apr 7, 2025
Completion
Apr 7, 2025

Study Design

Enrollment
303 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enlicitide Decanoate
    Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
  • Placebo Comparator: Placebo
    Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.

Primary Outcome Measure

Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Alliance for Multispecialty Research, LLC ( Site 0023)DaphneAlabama36526-
Excel Medical Clinical Trials ( Site 0008)Boca RatonFlorida33434-
Advanced Pharma Research ( Site 0007)Cutler BayFlorida33189-
Progressive Medical Research ( Site 0021)Port OrangeFlorida32127-
Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)Winter ParkFlorida32789-
Synexus Clinical Research US - Evansville ( Site 0031)EvansvilleIndiana47714-
Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)IndianapolisIndiana46237-
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)TroyMichigan48098-
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)LincolnNebraska68506-
Jubilee Clinical Research ( Site 0030)Las VegasNevada89106-
Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)Winston-SalemNorth Carolina27157-
Velocity Clinical Research, Salt Lake City ( Site 0004)West JordanUtah84088-
Health Research of Hampton Roads, Inc. ( Site 0020)Newport NewsVirginia23606-

Find similar trials in Daphne, AL

By research site
Alliance for Multispecialty Research, LLC· Daphne, ALExcel Medical Clinical Trials· Boca Raton, FLAdvanced Pharma Research· Cutler Bay, FLProgressive Medical Research· Port Orange, FLClinical Site Partners LLC, dba CSP Orlando· Winter Park, FLSynexus Clinical Research US - Evansville· Evansville, IN

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