Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
- Conditions
- Non-alcoholic Fatty Liver DiseaseLiver DiseaseMetabolic Dysfunction-Associated Steatotic Liver DiseaseNonalcoholic Fatty Liver Disease
- Interventions
- Registration Number
- NCT06482112
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 129
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efinopegdutide Q1W 10 mg Efinopegdutide Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. Efinopegdutide Q2W 15 mg Efinopegdutide Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. Efinopegdutide Q2W 10 mg Efinopegdutide Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.
- Primary Outcome Measures
Name Time Method Mean relative reduction from baseline in liver fat content (LFC) at Week 28 Baseline and 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.
Percentage of participants who experienced an adverse event (AE) Up to Week 32 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.
Percentage of pariticpants who discontinued study intervention due to an AE Up to Week 28 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.
- Secondary Outcome Measures
Name Time Method Mean percent change from baseline in body weight at Week 28 Baseline and 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.
Trial Locations
- Locations (39)
Gastroenterology and Liver Institute ( Site 0263)
🇺🇸Escondido, California, United States
Excel Medical Clinical Trials ( Site 0268)
🇺🇸Boca Raton, Florida, United States
Neoclinical Research ( Site 0275)
🇺🇸Hialeah, Florida, United States
Houston Research Institute ( Site 0221)
🇺🇸Houston, Texas, United States
South Ogden Family Medicine/ CCT Research ( Site 0255)
🇺🇸South Ogden, Utah, United States
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0
🇺🇸Chandler, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)
🇺🇸Peoria, Arizona, United States
Arizona Liver Health ( Site 0211)
🇺🇸Tucson, Arizona, United States
Del Sol Research Management, LLC ( Site 0209)
🇺🇸Tucson, Arizona, United States
Om Research LLC ( Site 0207)
🇺🇸Camarillo, California, United States
Velocity Clinical Research, Gardena ( Site 0235)
🇺🇸Gardena, California, United States
Velocity Clinical Research, Huntington Park ( Site 0210)
🇺🇸Huntington Park, California, United States
California Liver Research Institute ( Site 0216)
🇺🇸Pasadena, California, United States
Acclaim Clinical Research ( Site 0241)
🇺🇸San Diego, California, United States
Velocity Clinical Research, Santa Ana ( Site 0250)
🇺🇸Santa Ana, California, United States
Velocity Clinical Research, Panorama City ( Site 0228)
🇺🇸Van Nuys, California, United States
AGA Clinical Trials ( Site 0274)
🇺🇸Hialeah, Florida, United States
Homestead Associates in Research, Inc. ( Site 0243)
🇺🇸Homestead, Florida, United States
Floridian Clinical Research, LLC ( Site 0208)
🇺🇸Miami Lakes, Florida, United States
Southeast Clinical Research Center ( Site 0223)
🇺🇸Dalton, Georgia, United States
Velocity Clinical Research Rockville ( Site 0245)
🇺🇸Rockville, Maryland, United States
The Machuca Foundation ( Site 0218)
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research, LLC ( Site 0200)
🇺🇸Las Vegas, Nevada, United States
Basil Clinical ( Site 0246)
🇺🇸Inwood, New York, United States
Lucas Research, Inc ( Site 0204)
🇺🇸Morehead City, North Carolina, United States
Texas Clinical Research Institute ( Site 0230)
🇺🇸Arlington, Texas, United States
Pinnacle Clinical Research ( Site 0203)
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Austin ( Site 0201)
🇺🇸Austin, Texas, United States
Pinnacle Clinical Research-Corpus Christi ( Site 0267)
🇺🇸Corpus Christi, Texas, United States
Zenos Clinical Research ( Site 0240)
🇺🇸Dallas, Texas, United States
South Texas Research Institute ( Site 0226)
🇺🇸Edinburg, Texas, United States
American Research Corporation ( Site 0234)
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)
🇺🇸San Antonio, Texas, United States
Impact Research Institute ( Site 0227)
🇺🇸Waco, Texas, United States
Olympus Family Medicine/CCT Research ( Site 0266)
🇺🇸Holladay, Utah, United States
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)
🇵🇷Caguas, Puerto Rico
Klinical Investigations Group-Clinical Research ( Site 0100)
🇵🇷San Juan, Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 0101)
🇵🇷San Juan, Puerto Rico