A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

NCT05877547
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Phase
Phase 2
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Recruitment status
Completed
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Participants
381
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2023-06-23
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Number of sites
175
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Summary
The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.
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Short title
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
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Official title
A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-12-29
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First posted
2023-05-26
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Registry last updated
2026-01-12
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Primary completion date
2025-12-29
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Start date
2023-06-23
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Actual participants
381
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Participants
381
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
175
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05877547
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ClinicalTrials.gov ID
NCT05877547
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52

    Timeframe: Week 52

    The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    Timeframe: Up to 60 weeks

    An adverse event (AE) is a health problem that happens or worsens during a study.

  3. Percentage of Participants Discontinuing Study Medication Due to an AE

    Timeframe: Up to 52 weeks

    An adverse event (AE) is a health problem that happens or worsens during a study.

  1. Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52

    Timeframe: Week 52

    Participants will be assessed using the NASH CRN scoring system evaluated by BICR for ≥1-stage improvement in fibrosis without worsening of steatohepatitis. Fibrosis is scored from stage 0 to 4 where 0 = None, 1=Perisinusoidal OR periportal, 2=Perisinusoidal AND portal/periportal, 3= Bridging fibrosis, 4=Cirrhosis. No worsening of steatohepatitis is defined as no increase in the ballooning, inflammation, or steatosis scores.

  2. Change from Baseline in Body Weight At Week 52

    Timeframe: Week 52

    Body weight (kg) will be measured using a standardized, digital scale. The percent change from baseline in body weight after 52 weeks will be reported.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
  • No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
  • Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

  • History of liver disease other than NASH
  • History or evidence of cirrhosis
  • History of pancreatitis
  • History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
  • History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
  • Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
Sources for eligibility
clinicaltrials.gov

  • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3Chandler, United States
  • The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)Peoria, United States
  • The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)Tucson, United States
  • Del Sol Research Management, LLC ( Site 3211)Tucson, United States
  • Om Research - Apple Valley ( Site 3244)Apple Valley, United States
  • Om Research LLC ( Site 3245)Camarillo, United States
  • Velocity Clinical Research, Gardena ( Site 3225)Gardena, United States
  • Velocity Clinical Research, Huntington Park ( Site 3217)Huntington Park, United States
  • Velocity Clinical Research, San Diego ( Site 3226)La Mesa, United States
  • Om Research LLC ( Site 3229)Lancaster, United States
  • Velocity Clinical Research, Westlake ( Site 3216)Los Angeles, United States
  • Velocity Clinical Research, Panorama City ( Site 3214)Panorama City, United States
  • California Liver Research Institute ( Site 3232)Pasadena, United States
  • Clinical Trials Research ( Site 3230)Sacramento, United States
  • Excel Medical Clinical Trials ( Site 3246)Boca Raton, United States
  • Synergy Healthcare ( Site 3286)Bradenton, United States
  • Synergy Healthcare LLC ( Site 3290)Brandon, United States
  • Top Medical Research ( Site 3209)Cutler Bay, United States
  • Covenant Metabolic Specialists, LLC ( Site 3231)Fort Myers, United States
  • Velocity Clinical Research, Hallandale Beach ( Site 3241)Hallandale, United States
  • Indago Research & Health Center, Inc ( Site 3207)Hialeah, United States
  • Sweet Hope Research Specialty, Inc-Research ( Site 3200)Hialeah, United States
  • Florida Research Institute ( Site 3243)Lakewood Rch, United States
  • Genoma Research Group ( Site 3242)Miami, United States
  • Floridian Clinical Research, LLC ( Site 3203)Miami Lakes, United States

And 150 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-6024-013
  • U1111-1285-0933
  • jRCT2031230187
  • 2022-502647-35-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (2)