A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis

In brief

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

Key facts

Study ID

NCT04583423

Run by

Merck Sharp & Dohme LLC

People needed

183

Starts

2020-11-11

Expected to finish

2023-04-13

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has histological confirmation of NASH
• Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
• Has a body mass index (BMI) ≥25 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months
• Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
• Contraceptive use by male participants should be consistent with local regulations.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.

You may not qualify if…

• Has presence of cirrhosis on liver biopsy
• Has Type 1 diabetes
• Has a history of malignancy, unless cancer free ≥5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• Has a history of bariatric surgery ≤5 years before study participation
• Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
• Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
• Has significant systemic or major illnesses other than liver disease, including recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation

Where it is running

• Arizona Liver Health ( Site 9026) — Tucson, Arizona, United States
• Del Sol Research Management ( Site 2674) — Tucson, Arizona, United States
• Arkansas Gastroenterology - North Little Rock ( Site 9015) — North Little Rock, Arkansas, United States
• Hope Clinical Research, Inc. ( Site 2601) — Canoga Park, California, United States
• Velocity Clinical Research, Huntington Park ( Site 9022) — Huntington Park, California, United States
• UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si — La Jolla, California, United States
• Ruane Clinical Research Group, Inc ( Site 9014) — Los Angeles, California, United States
• Velocity Clinical Research, Westlake ( Site 9013) — Los Angeles, California, United States
• Catalina Research Institute, LLC ( Site 2643) — Montclair, California, United States
• Velocity Clinical Research, Panorama City ( Site 9001) — Panorama City, California, United States
• California Liver Research Institute ( Site 9025) — Pasadena, California, United States
• Quest Clinical Research ( Site 9011) — San Francisco, California, United States
• Velocity Clinical Research, Santa Ana ( Site 9002) — Santa Ana, California, United States
• Peak Gastroenterology Associates ( Site 2645) — Colorado Springs, Colorado, United States
• Top Medical Research, Inc ( Site 2673) — Cutler Bay, Florida, United States
• Covenant Metabolic Specialists, LLC ( Site 9027) — Fort Myers, Florida, United States
• North Florida South Georgia Veterans Health System ( Site 2613) — Gainesville, Florida, United States
• Indago Research and Health Center Inc ( Site 2610) — Hialeah, Florida, United States
• Sweet Hope Research Specialty Inc ( Site 2660) — Hialeah, Florida, United States
• Genoma Research Group, Inc. ( Site 2669) — Miami, Florida, United States
• Floridian Clinical Research, LLC ( Site 2656) — Miami Lakes, Florida, United States
• Ocean Blue Medical Research Center Inc ( Site 2667) — Miami Springs, Florida, United States
• Sensible Healthcare Llc ( Site 2607) — Ocoee, Florida, United States
• Synexus Research ( Site 2672) — Orlando, Florida, United States
• Adobe Clinical Research, LLC ( Site 2644) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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