GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

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

Status
CompletedResults posted
Why it is watched
non-weight indication: liver, addiction
Who it enrolls
age 18 Years to 70 Years; excludes diabetes; BMI ≥25 required; conditions: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
Interventions
Efinopegdutide 20 mg/mL; Semaglutide 1.34 mg/mL
Conditions
Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
Phase and size
Phase 2 · 145 participants
Dates
Start 2021-08-04
Primary completion 2022-10-19
Sponsor
Merck Sharp & Dohme LLC (Industry)
Last checked
Sep 13, 2026
01Endpoints

What the trial will measure

  • 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 WeeksBaseline and up to ~24 Weeks
  • Percentage of Participants Who Experienced an Adverse Event (AE)Up to ~29 weeks
  • Percentage of Participants Who Discontinued Study Intervention Due to an AEUp to ~24 weeks
02Eligibility

Who can take part

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.
03Change log

Registry changes

No changes recorded since the trial was added.