GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)

A Phase 2a Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of Efinopegdutide (MK-6024) in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

124

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criteria

•BMI ≥25•HbA1c ≤9%

Primary endpoints

•Mean Relative Reduction From Baseline in Liver Fat Content•Adverse Event (AE)•Percentage of Participants Who Discontinued Study Intervention Due to an 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 IDNCT06482112

Org study ID6024-016

Secondary IDMK-6024-016MSD

Timeline

Milestones

Study first posted2024-07-01actual

Study start2024-07-29actual

Primary completion2025-06-27actual

Study completion2025-06-27actual

Last update posted2026-06-01actual

Results first posted2026-06-01actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

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 body mass index (BMI) ≥25 kg/m^2 (≥23 kg/m^2 for Asian participants) AND has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening

•Has no history of type 2 diabetes mellitus (T2DM) OR has a history of T2DM with a glycated hemoglobin (A1C) ≤9% AND the T2DM is controlled by diet or stable doses of oral antihyperglycemic agents (AHAs)

Exclusion criteria

The main exclusion criteria include but are not limited to the following

•Has a history or evidence of chronic liver disease other than Metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic dysfunction-associated steatohepatitis (MASH)

•Has evidence of decompensated liver disease including, but not limited to ascites, esophageal or gastric variceal bleeding, hepatocellular carcinoma, hepatic encephalopathy, splenomegaly, or spontaneous bacterial peritonitis

•Has a history of pancreatitis

•Has a history of type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy.

•Has symptomatic hyperglycemia

•Has a history of a bariatric surgical procedure ≤5 years before Screening or a known clinically significant gastric emptying abnormality

•Has a history of obesity with a known secondary cause

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

•Is unable to have Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) due to: Claustrophobia to a degree that prevents tolerance of an MRI-PDFF scanning procedure. Note: Sedation is permitted, at the discretion of the investigator; Metallic implants that prevent MRI-PDFF examination; Exceeds the body habitus and/or weight limitations for the MRI scanner

Endpoints (8)

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

Safety / tolerability / PK

Weight & body composition

MASH / liver

Weight & body composition

2 endpoints

Secondary/registry result

Mean Percent Change From Baseline in Body Weight at Week 28

Time frame:Baseline and Week 28

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide Q1W 10 mg	-7.5	-8.8 – -6.1
Efinopegdutide Q2W 10 mg	-3.9	-5.3 – -2.5
Efinopegdutide Q2W 15 mg	-4.1	-5.5 – -2.7

Secondary/protocol endpoint

Mean percent change from baseline in body weight at Week 28

Time frame:Baseline and Week 28

Body weight, % change

percent change from baseline, improvement

MASH / liver

2 endpoints

Primary/registry result

Mean Relative Reduction From Baseline in Liver Fat Content at Week 28

Time frame:Baseline and Week 28

descriptive

Posted result

Group	Value (least_squares_mean), Percent Reduction	95% CI
Efinopegdutide Q1W 10 mg	67.8	60.7 – 74.9
Efinopegdutide Q2W 10 mg	54.4	46.8 – 61.9
Efinopegdutide Q2W 15 mg	42.1	34.6 – 49.5

Primary/protocol endpoint

Mean relative reduction from baseline in liver fat content (LFC) at Week 28

Time frame:Baseline and Week 28

Liver fat content, change

percent change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/registry result

Percentage of Participants Who Experienced an Adverse Event (AE)

Time frame:Up to Week 32

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	95% CI
Efinopegdutide Q1W 10 mg	83.3	—
Efinopegdutide Q2W 10 mg	82.1	—
Efinopegdutide Q2W 15 mg	85.7	—

Primary/registry result

Percentage of Participants Who Discontinued Study Intervention Due to an AE

Time frame:Up to Week 28

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	95% CI
Efinopegdutide Q1W 10 mg	7.1	—
Efinopegdutide Q2W 10 mg	5.1	—
Efinopegdutide Q2W 15 mg	9.5	—

Primary/protocol endpoint

Percentage of participants who experienced an adverse event (AE)

Time frame:Up to Week 32

Treatment-emergent AEs (any)

threshold achievement, event

Primary/protocol endpoint

Percentage of pariticpants who discontinued study intervention due to an AE

Time frame:Up to Week 28

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 tableClinicalTrials.gov results section

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.