Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
NCT Number: NCT06482112
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease|Non-alcoholic Fatty Liver Disease|Nonalcoholic Fatty Liver Disease|Liver Disease
Interventions: DRUG: Efinopegdutide
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2025-10-16
Locations: Floridian Clinical Research, LLC ( Site 0208), Miami Lakes, Florida, 33016-1518, United States|American Research Corporation ( Site 0234), San Antonio, Texas, 78215, United States|Clinical Trials of Texas, LLC-Clinical Research ( Site 0252), San Antonio, Texas, 78229, United States|Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229), San Antonio, Texas, 78229, United States|Klinical Investigations Group-Clinical Research ( Site 0100), San Juan, 00909, Puerto Rico

Summary:
This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.

Primary Outcome Measures: Mean relative reduction from baseline in liver fat content (LFC) at Week 28, LFC will be measured with liver images taken by Magnetic Resonance Imaging Estimated Proton Density Fat Fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Mean relative reduction from baseline in LFC will be presented., Baseline and Week 28|Percentage of participants who experienced an adverse event (AE), An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE will be presented., Up to Week 32|Percentage of pariticpants who discontinued study intervention due to an AE, An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE will be presented., Up to Week 28
Secondary Outcome Measures: Mean percent change from baseline in body weight at Week 28, Body weight in kilograms will be measured using a standardized, digital scale. The mean percent change from baseline in body weight after 28 weeks will be presented., Baseline and Week 28