A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
- Conditions
- Non-alcoholic Fatty Liver DiseaseFatty Liver, NonalcoholicNAFLDNonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT05877547
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 360
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered by SC injection once weekly for 52 weeks Efinopegdutide 7mg Efinopegdutide Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks. Efinopegdutide 10mg Efinopegdutide Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks. Semaglutide 2.4 mg Semaglutide Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks. Efinopegdutide 4mg Efinopegdutide Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52 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.
Percentage of Participants Who Experienced an Adverse Event (AE) Up to 60 weeks An adverse event (AE) is a health problem that happens or worsens during a study.
Percentage of Participants Discontinuing Study Medication Due to an AE Up to 52 weeks An adverse event (AE) is a health problem that happens or worsens during a study.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52 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.
Change from Baseline in Body Weight At Week 52 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.
Trial Locations
- Locations (175)
Om Research - Apple Valley ( Site 3244)
🇺🇸Apple Valley, California, United States
Velocity Clinical Research, Austin ( Site 3235)
🇺🇸Austin, Texas, United States
Barzilai Medical Center ( Site 1306)
🇮🇱Ashkelon, Israel
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)
🇲🇽Monterrey, Nuevo Leon, Mexico
Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1905)
🇵🇹Guimaraes, Braga, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 1906)
🇵🇹Lisbon, Lisboa, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1904)
🇵🇹Lisbon, Lisboa, Portugal
St James's University Hospital ( Site 3005)
🇬🇧Leeds, United Kingdom
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
🇺🇸Chandler, Arizona, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
🇺🇸Peoria, Arizona, United States
Scroll for more (165 remaining)Om Research - Apple Valley ( Site 3244)🇺🇸Apple Valley, California, United States