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A 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510923-20-00
Acronym
MK-6024-017
Enrollment
24
Registered
2024-08-05
Start date
2024-09-16
Completion date
Unknown
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Brief summary

Change from baseline in liver fat content (LFC) at week 28, Percentage of participants who experienced an adverse event (AE), Percentage of participants discontinuing study medication due to an AE

Detailed description

Change from baseline in iron-corrected T1 (cT1) at week 28, Change from baseline in enhanced liver fibrosis (ELF) score at week 28, Change from baseline in propeptide of type III collagen (Pro-C3) at week 28, Change from baseline in fibrosis-4 index (FIB-4) at week 28, Change from baseline in liver stiffness measurement (LSM) assessed by vibration-controlled transient elastography (VCTE) at week 28, Percent change from baseline in body weight at week 28

Interventions

DRUGPlacebo to MK-6024

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in liver fat content (LFC) at week 28, Percentage of participants who experienced an adverse event (AE), Percentage of participants discontinuing study medication due to an AE

Secondary

MeasureTime frame
Change from baseline in iron-corrected T1 (cT1) at week 28, Change from baseline in enhanced liver fibrosis (ELF) score at week 28, Change from baseline in propeptide of type III collagen (Pro-C3) at week 28, Change from baseline in fibrosis-4 index (FIB-4) at week 28, Change from baseline in liver stiffness measurement (LSM) assessed by vibration-controlled transient elastography (VCTE) at week 28, Percent change from baseline in body weight at week 28

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026