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Active, Not Recruiting

NCT Number: NCT06465186

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Metabolic Dysfunction-Associated Steatohepatitis Metabolic Dysfunction-Associated Steatotic Liver Disease NAFLD Nonalcoholic Steatohepatitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202), Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efinopegdutide

Combination Product

Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks

Other names: MK-6024

Placebo

Combination Product

Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

Primary outcomes

  1. Change from Baseline in Liver Fat Content (LFC) at Week 28

    Time frame: 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.

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to approximately 36 weeks

    An AE is a health problem that happens or worsens during the study

  3. Percentage of Participants Discontinuing Study Medication Due to an AE

    Time frame: 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.

Secondary outcomes

  1. Change from Baseline in Iron-corrected T1 (cT1) at Week 28

    Time frame: 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.

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

    Time frame: 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.

  3. Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28

    Time frame: 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.

  4. Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28

    Time frame: 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.

  5. Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28

    Time frame: 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.

  6. Percent Change from Baseline in Body Weight at Week 28

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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