A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

Part of paid clinical trials in Montclair, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04944992
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Efinopegdutide 20 mg/mL — DRUG
    Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
  • Semaglutide 1.34 mg/mL — DRUG
    Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg

Study Details

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Key Dates

Start date
Aug 4, 2021
Status verified
Oct 2023
Primary completion
Oct 19, 2022
Completion
Oct 19, 2022

Study Design

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

Arms

  • Experimental: Efinopegdutide
    Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.
  • Active Comparator: Semaglutide
    Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.

Primary Outcome Measure

Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks [ Time Frame: Baseline and up to ~24 Weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
Catalina Research Institute, LLC ( Site 1939)MontclairCalifornia91763-
Sweet Hope Research Specialty, Inc ( Site 1902)HialeahFlorida33016-
Floridian Clinical Research, LLC ( Site 1950)Miami LakesFlorida33016-
Sensible Healthcare, LLC ( Site 1903)OcoeeFlorida34761-
Lucas Research, Inc ( Site 1930)Morehead CityNorth Carolina28557-
Texas Clinical Research Institute ( Site 1910)ArlingtonTexas76012-
Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)HoustonTexas77030-
American Research Corporation at Texas Liver Institute ( Site 1920)San AntonioTexas78215-
Clinical Trials of Texas, Inc. ( Site 1906)San AntonioTexas78229-

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By research site
Catalina Research Institute, LLC· Montclair, CASweet Hope Research Specialty, Inc· Hialeah, FLFloridian Clinical Research, LLC· Miami Lakes, FLSensible Healthcare, LLC· Ocoee, FLLucas Research, Inc· Morehead City, NCTexas Clinical Research Institute· Arlington, TX

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