A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)

Phase 2

Recruiting

• Conditions: NAFLD; Metabolic Dysfunction-associated Steatotic Liver Disease; Non-alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Metabolic Dysfunction-associated Steatohepatitis

• Registration Number: NCT06465186
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:

* If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver

* About the safety of efinopegdutide and how well people tolerate it

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Study Start: 2024-07-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-09-21
• Study Completion: 2026-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

• Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
• Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

• Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
• Has history of type 1 diabetes
• Had a bariatric surgical procedure less than 5 years before entry into the study
• History of pancreatitis
• Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Liver Fat Content (LFC) at Week 28	Baseline and 28 weeks	Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment.; The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks.
Percentage of Participants Discontinuing Study Medication Due to an AE	Up to approximately 28 weeks	An AE is a health problem that happens or worsens during a study. The percentage of participants who stop study treatment due to an AE will be reported.
Percentage of Participants Who Experienced an Adverse Event (AE)	Up to approximately 36 weeks	An AE is a health problem that happens or worsens during the study

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28	Baseline and up to 28 weeks	Researchers will measure the change in liver scarring using biomarkers.; FIB-4 index is calculated using the participant's age and 3 serum markers (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and platelet count). The change from baseline in FIB-4 after 28 weeks will be reported.
Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28	Baseline and up to 28 weeks	Researchers will measure the change in liver scarring using ultrasound.; LSM is measured using VCTE. The change from baseline in LSM after 28 weeks will be reported.
Percent Change from Baseline in Body Weight at Week 28	Baseline and up to approximately 28 weeks	Body weight will be measured using a standardized, digital scale. The percent change from baseline in body weight after 28 weeks will be reported
Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28	Baseline and up to 28 weeks	Researchers will measure the change in liver scarring using biomarkers. Biomarkers are substances measured in blood that show normal or abnormal activity taking place in the liver.; ELF is calculated using 3 markers of hepatic extracellular matrix turnover to generate a unitless numerical score. The change from baseline in ELF up to 28 weeks will be reported.
Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28	Baseline and up to 28 weeks	Researchers will measure the change in liver scarring using biomarkers.; Pro-C3 is measured in serum; Increasing levels indicate worsening of fibrosis activity. The change in Pro-C3 from baseline to 28 weeks will be reported.
Change from Baseline in Iron-corrected T1 (cT1) at Week 28	Baseline and up to 28 Weeks	Researchers will measure the change in liver inflammation and scarring (fibrosis) after about 7 months of treatment.; MRI measurement of cT1 mapping will be used to indicate the amount of liver inflammation and fibrosis. The change in cT1 mapping from baseline to 28 weeks will be presented.

Trial Locations

Locations (68)

The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149); 🇺🇸 Chandler, Arizona, United States

Arizona Clinical Trials ( Site 0158); 🇺🇸 Flagstaff, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120); 🇺🇸 Peoria, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111); 🇺🇸 Tucson, Arizona, United States

California Liver Research Institute ( Site 0113); 🇺🇸 Pasadena, California, United States

Acclaim Clinical Research ( Site 0137); 🇺🇸 San Diego, California, United States

Velocity Clinical Research, Panorama City ( Site 0124); 🇺🇸 Van Nuys, California, United States

Rocky Mountain Gastroenterology ( Site 0127); 🇺🇸 Littleton, Colorado, United States

Synergy Healthcare ( Site 0118); 🇺🇸 Bradenton, Florida, United States

Homestead Associates in Research, Inc. ( Site 0139); 🇺🇸 Homestead, Florida, United States

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