GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

Lead sponsor

Merck Sharp & Dohme LLC

Assets

Efinopegdutide / Semaglutide

Listed sites

175

Recruiting sites

—

Enrollment

381

actual

Study population

MASH / NAFLD / liver fibrosis

Key I/E criterion

•HbA1c ≤9%

Primary endpoints

•MASH resolution, no fibrosis worsening•Treatment-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 IDNCT05877547

Org study ID6024-013

Secondary ID2022-502647-35-00EU CT

Secondary IDjRCT2031230187jRCT

Secondary IDMK-6024-013MSD

Secondary IDU1111-1285-0933UTN

Timeline

Milestones

Study first posted2023-05-26actual

Study start2023-06-23actual

Primary completion2025-12-29actual

Study completion2025-12-29actual

Last update posted2026-01-12actual

Assets

Investigational agents

Efinopegdutide Semaglutide

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

•Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3

•No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)

•Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

Exclusion criteria

•History of liver disease other than NASH

•History or evidence of cirrhosis

•History of pancreatitis

•History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy

•History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality

•Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack

Endpoints (5)

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

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Body Weight At Week 52

Time frame:Week 52

Body weight, % change

percent change from baseline, improvement

MASH / liver

2 endpoints

Primary/protocol endpoint

Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52

Time frame:Week 52

MASH resolution, no fibrosis worsening

categorical status, improvement

SNOMED 442685003

Secondary/protocol endpoint

Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52

Time frame:Week 52

Fibrosis ≥1-stage improvement, no MASH worsening

threshold achievement, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Percentage of Participants Who Experienced an Adverse Event (AE)

Time frame:Up to 60 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 52 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.