A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
NCT Number: NCT06465186
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis|NAFLD|Metabolic Dysfunction-associated Steatotic Liver Disease|Metabolic Dysfunction-associated Steatohepatitis
Interventions: COMBINATION_PRODUCT: Efinopegdutide|COMBINATION_PRODUCT: Placebo
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2026-05-15
Locations: Synergy Healthcare ( Site 0118), Bradenton, Florida, 34208, United States|Floridian Clinical Research, LLC ( Site 0109), Miami Lakes, Florida, 33016-1518, United States|Klinical Investigations Group-Clinical Research ( Site 0601), San Juan, 00909, Puerto Rico

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

Primary Outcome Measures: Change from Baseline in Liver Fat Content (LFC) at Week 28, 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., Baseline and 28 weeks|Percentage of Participants Who Experienced an Adverse Event (AE), An AE is a health problem that happens or worsens during the study, Up to approximately 36 weeks|Percentage of Participants Discontinuing Study Medication Due to an AE, 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., Up to approximately 28 weeks
Secondary Outcome Measures: Change from Baseline in Iron-corrected T1 (cT1) at Week 28, 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., Baseline and up to 28 Weeks|Change from Baseline in Enhanced Liver Fibrosis (ELF), 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., Baseline and up to 28 weeks|Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28, 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., Baseline and up to 28 weeks|Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28, 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., Baseline and up to 28 weeks|Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28, 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., Baseline and up to 28 weeks|Percent Change from Baseline in Body Weight at Week 28, Body weight will be measured using a standardized, digital scale. The percent change from baseline in body weight after 28 weeks will be reported, Baseline and up to approximately 28 weeks