Clinical trial NCT06482112: Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
Official title: A Phase 2a Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of Efinopegdutide (MK-6024) in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Non-alcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver Disease
Liver Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Mean relative reduction from baseline in liver fat content (LFC) at Week 28
timeFrame: Baseline and Week 28
measure: Percentage of participants who experienced an adverse event (AE)
timeFrame: Up to Week 32
measure: Percentage of pariticpants who discontinued study intervention due to an AE
timeFrame: Up to Week 28
Secondary outcomes:
measure: Mean percent change from baseline in body weight at Week 28
timeFrame: Baseline and Week 28
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0
state: Arizona
city: Peoria
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health ( Site 0211)
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC ( Site 0209)
state: Arizona
city: Camarillo
country: United States
facility: Om Research LLC ( Site 0207)
state: California
city: Escondido
country: United States
facility: Gastroenterology and Liver Institute ( Site 0263)
state: California
city: Gardena
country: United States
facility: Velocity Clinical Research, Gardena ( Site 0235)
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park ( Site 0210)
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute ( Site 0216)
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research ( Site 0241)
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research, Santa Ana ( Site 0250)
state: California
city: Van Nuys
country: United States
facility: Velocity Clinical Research, Panorama City ( Site 0228)
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials ( Site 0268)
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials ( Site 0274)
state: Florida
city: Hialeah
country: United States
facility: Neoclinical Research ( Site 0275)
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research, Inc. ( Site 0243)
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC ( Site 0208)
state: Florida
city: Dalton
country: United States
facility: Southeast Clinical Research Center ( Site 0223)
state: Georgia
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville ( Site 0245)
state: Maryland
city: Las Vegas
country: United States
facility: The Machuca Foundation ( Site 0218)
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC ( Site 0200)
state: Nevada
city: Inwood
country: United States
facility: Basil Clinical ( Site 0246)
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc ( Site 0204)
state: North Carolina
city: Arlington
country: United States
facility: Texas Clinical Research Institute ( Site 0230)
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research ( Site 0203)
state: Texas
city: Austin
country: United States
facility: Velocity Clinical Research, Austin ( Site 0201)
state: Texas
city: Corpus Christi
country: United States
facility: Pinnacle Clinical Research-Corpus Christi ( Site 0267)
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research ( Site 0240)
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute ( Site 0226)
state: Texas
city: Houston
country: United States
facility: Houston Research Institute ( Site 0221)
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation ( Site 0234)
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)
state: Texas
city: Waco
country: United States
facility: Impact Research Institute ( Site 0227)
state: Texas
city: Holladay
country: United States
facility: Olympus Family Medicine/CCT Research ( Site 0266)
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine/ CCT Research ( Site 0255)
state: Utah
city: Caguas
country: Puerto Rico
facility: San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group-Clinical Research ( Site 0100)
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials - Ciudadela ( Site 0101)
Study officials:
affiliation: Merck Sharp and Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: