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Active not recruitingPhase 2

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

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

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

68

Recruiting sites

Enrollment

80

estimated

Study population

MASH / NAFLD / liver fibrosis

Key I/E criterion

Primary endpoints

Liver fat content, changeTreatment-emergent AEs (any)Discontinuation due to AE

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06465186
Org study ID6024-017
Secondary ID2024-510923-20-00EU CT
Secondary IDjRCT2031240217jRCT
Secondary IDMK-6024-017MSD
Secondary IDU1111-1302-7589UTN

Timeline

Milestones

Study first posted2024-06-18actual
Study start2024-07-12actual
Last update posted2026-03-02actual
Primary completion2026-08-06estimated
Study completion2026-08-06estimated

Assets

Investigational agents

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
6
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Body Weight at Week 28

Time frame:Baseline and up to approximately 28 weeks

Body weight, % change

percent change from baseline, improvement

MASH / liver

6 endpoints
Primary/protocol endpoint

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

Time frame:Baseline and 28 weeks

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and up to 28 Weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and up to 28 weeks

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and up to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and up to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Liver stiffness (VCTE), change

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Percentage of Participants Who Experienced an Adverse Event (AE)

Time frame:Up to approximately 36 weeks

Treatment-emergent AEs (any)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants Discontinuing Study Medication Due to an AE

Time frame:Up to approximately 28 weeks

Discontinuation due to AE

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.