Metabolic Dysfunction-associated Steatohepatitis, Metabolic Dysfunction-associated Steatotic Liver Disease, NAFLD, Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Conditions
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
Interventions
COMBINATION_PRODUCTEfinopegdutide
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
COMBINATION_PRODUCTPlacebo
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Who Experienced an Adverse Event (AE) | Up to approximately 36 weeks | An AE is a health problem that happens or worsens during the study |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
Countries
Australia, Canada, Colombia, France, Israel, Japan, Puerto Rico, Spain, Thailand, United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed