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

Phase 2Active Not RecruitingNCT06465186

Merck Sharp & Dohme LLC80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis NAFLD Metabolic Dysfunction-associated Steatotic Liver Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: Up to approximately 28 weeks

Secondary Outcomes

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.

Time frame: Baseline and up to 28 Weeks

Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Baseline and up to approximately 28 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (68)

Outcomes

Primary Outcomes

Secondary Outcomes