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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465186
• Other study ID #: 6024-017
• Secondary ID: 2024-510923-20MK
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 18, 2024
• Est. completion date: May 15, 2026

Study information

• Verified date: June 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 15, 2026
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Combination Product:
• Efinopegdutide
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
• Placebo
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Merck Clinical Trials Information