GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease

Lead sponsor

Merck Sharp & Dohme LLC

Assets

Efinopegdutide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

145

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criteria

•BMI ≥25•HbA1c ≤8.5%

Primary endpoints

•Liver fat content, change•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 IDNCT04944992

Org study ID6024-001

Secondary IDMK-6024-001Merck

Timeline

Milestones

Study first posted2021-06-30actual

Study start2021-08-04actual

Primary completion2022-10-19actual

Study completion2022-10-19actual

Last update posted2023-11-15actual

Results first posted2023-11-15actual

Assets

Investigational agents

Efinopegdutide Semaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•LFC ≥10% as assessed by MRI-PDFF at time of screening.

•Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening.

•Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit.

•No history of Type 2 Diabetes Mellitus (T2DM) OR history of T2DM with an Glycated Hemoglobin (A1C) ≤8.5% at screening AND controlled by diet or a stable dose of metformin for the 3 months before screening.

•A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 5 weeks after the last dose of study intervention.

•Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive).

•Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive).

Exclusion criteria

•History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy.

•Ongoing, inadequately controlled hypothyroidism or hyperthyroidism.

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome.

•Recent event (within 6 months prior to screening) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack.

•History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH).

•Known history of cirrhosis.

•History of acute or chronic pancreatitis.

•History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality.

•History of malignancy ≤5 years prior to screening, except for skin cancer or cervical cancer.

•Clinically active hematologic disorder.

•Diagnosis of human immunodeficiency virus (HIV).

•Surgery requiring general anesthesia within 3 months before screening visit.

•History of organ transplantation, except for corneal transplant.

•Active diabetic proliferative retinopathy or a history of maculopathy.

•Untreated obstructive sleep apnea.

•History of treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 months before screening.

•History of treatment with thiazolidinediones (ie, pioglitazone, rosiglitazone) within 6 months before screening.

•Previous use (within 3 months before screening) or current use of prescription weight-management medications or over-the-counter weight-loss medications or therapies.

•Treatment with systemic corticosteroid medication within 3 months before screening.

•Current treatment with anticoagulants (eg, warfarin, heparin).

•Inability to have an MRI-PDFF performed due to either severe claustrophobia, metallic implant that prevents MRI-PDFF examination, or any other contraindication to MRI-PDFF examination.

•Previous or current history of significant alcohol consumption (average of 7 standard drinks per week in females or 14 standard drinks per week in males) for a period of more than 3 consecutive months in the 24 months before screening.

Endpoints (22)

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

Cardiometabolic biomarkers

MASH / liver

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Mean Percent Change From Baseline in Body Weight After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-8.5	-9.5 – -7.5
Semaglutide	-7.1	-8.1 – -6.2

Difference in Least Squared Means-1.490% CI-2.7 – -0.1p0.085Mixed Models Analysis

Secondary/protocol endpoint

Mean Percent Change From Baseline in Body Weight After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Body weight, % change

percent change from baseline, improvement

MASH / liver

4 endpoints

Primary/registry result

Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks

Time frame:Baseline and up to ~24 Weeks

Liver fat content, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Reduction	95% CI
Efinopegdutide	72.7	66.8 – 78.7
Semaglutide	42.3	36.5 – 48.1

Difference in least squared means30.490% CI22.1 – 38.7p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Time frame:Baseline and up to ~24 Weeks

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/registry result

Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks

Time frame:Baseline and up to ~24 Weeks

Liver fat content, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of liver fat	95% CI
Efinopegdutide	14.9	13.6 – 16.3
Semaglutide	8.8	7.5 – 10.1

Difference in least squared means6.190% CI4.6 – 7.7p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks

Time frame:Baseline and up to ~24 Weeks

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints

Secondary/registry result

Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-15.2	-18.2 – -12.2
Semaglutide	-8.0	-11.0 – -5.0

Difference in Least Squared Means-7.290% CI-11.2 – -3.1

Secondary/registry result

Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Non-HDL cholesterol, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-16.8	-20.5 – -13.0
Semaglutide	-11.0	-14.8 – -7.3

Difference in least squared means-5.790% CI-10.9 – -0.6

Secondary/registry result

Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-8.1	-11.2 – -5.1
Semaglutide	3.6	0.6 – 6.6

Difference in least squared means-11.790% CI-15.8 – -7.7

Secondary/registry result

Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-13.0	-17.4 – -8.6
Semaglutide	-6.9	-11.3 – -2.6

Difference in least squared means-6.190% CI-12.0 – -0.1

Secondary/registry result

Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-30.9	-35.6 – -25.8
Semaglutide	-23.3	-28.5 – -17.7

Difference in least squared means-7.690% CI-14.3 – -0.9

Secondary/registry result

Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

ApoB, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Efinopegdutide	-14.7	-18.2 – -11.1
Semaglutide	-9.2	-12.8 – -5.7

Difference in least squared means-5.490% CI-10.4 – -0.4

Secondary/protocol endpoint

Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks

Time frame:Baseline and up to ~24 weeks

ApoB, 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 ~29 weeks

Treatment-emergent AEs (any)

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Efinopegdutide	88.9	—
Semaglutide	72.6	—

difference in percentage16.395% CI3.5 – 29.1

Primary/registry result

Percentage of Participants Who Discontinued Study Intervention Due to an AE

Time frame:Up to ~24 weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Efinopegdutide	5.6	—
Semaglutide	0	—

Difference in percentage5.695% CI0.4 – 13.5

Primary/protocol endpoint

Percentage of Participants Who Experienced an Adverse Event (AE)

Time frame:Up to ~29 weeks

Treatment-emergent AEs (any)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants Who Discontinued Study Intervention Due to an AE

Time frame:Up to ~24 weeks

Discontinuation due to AE

threshold achievement, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.
Journal of hepatology2023 Oct (month)PMID37355043doi:10.1016/j.jhep.2023.05.013via CT.gov reference + pubmed nct search

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.