LivingGLP1
Study S000186

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

ClinicalTrials.gov recordStudy Protocol and Statistical Analysis Plan (PDF)

Registration

Registration
NCT04944992
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
NONE
Status
COMPLETED
Enrollment
145
Start
2021-08-04
Primary completion
2022-10-19
Lead sponsor
Merck Sharp & Dohme LLC
Conditions
Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
Interventions
DRUG:Efinopegdutide 20 mg/mL; DRUG:Semaglutide 1.34 mg/mL
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:MK-6024-001; EUDRACT_NUMBER:2020-005136-30

Registered primary outcomes

  • 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 [Baseline 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 AE [Up to ~24 weeks]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0009070A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.
Romero-Gómez M, Journal of hepatology
2023Randomized trialPMID 37355043DOIcites ClinicalTrials.gov:NCT04944992; cites EudraCT:2020-005136-30; registry reference RESULT:37355043
R0040528From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis
Manik Aggarwal, Clinical Liver Disease
2023OtherPMID 36938314DOIcites ClinicalTrials.gov:NCT04944992