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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: MK-3655; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04583423

MK-3655-001 (Other Identifier)

jRCT2051200083 (Registry Identifier)

2019-003048-63 (EudraCT Number)

3655-001

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 4 patient groups, including a placebo group

MK-3655 50 mg

Experimental group

Description:

Following a 2-week placebo run-in, participants will receive MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.

Treatment:

Drug: MK-3655

MK-3655 100 mg

Experimental group

Description:

Following a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.

Treatment:

Drug: MK-3655

MK-3655 300 mg

Experimental group

Description:

Following a 2-week placebo run-in, participants will receive MK-3655 300 mg by SC injection Q4W for 52 weeks.

Treatment:

Drug: MK-3655

Placebo

Placebo Comparator group

Description:

Following a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.

Treatment:

Drug: Placebo