A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis

JRCT ID: jRCT2051200083

Registered date:10/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nonalcoholic Steatohepatitis
• Date of first enrollment: 06/01/2021
• Target sample size: 328
• Countries of recruitment: United States,Japan,Canada,Japan,Mexico,Japan,Chile,Japan,Argentina,Japan,Turkey,Japan,Russia,Japan,Italy,Japan,Israel,Japan,France,Japan,Spain,Japan,Germany,Japan,Taiwan,Japan,New Zealand,Japan,Australia,Japan,South Korea,Japan,Hong Kong,Japan,China,Japan,Columbia,Japan,Puerto Rico,Japan,Malaysia,Japan,Sweden,Japan,Greece,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

MK-3655: low, middle, or high dose for injection
Placebo: Matching placebo to MK-3655

Outcome(s)

Primary Outcome

1. Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks
2. Percentage of Participants Who Experienced an Adverse Event (AE)
3. Percentage of Participants Discontinuing Study Medication Due to an AE

Secondary Outcome

1. Mean Percent Change from Baseline in Liver Fat Content (LFC) After 24 Weeks
2. Percentage of Participants With >=1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks
3. Percentage of Participants With >=2 Point Improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) Without Worsening of Fibrosis After 52 Weeks

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Has histological confirmation of NASH
2. Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
3. Has a body mass index (BMI)>=25 kg/m2 and<=50 kg/m2 and stable weight for the past 3 months
4. Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
5. Contraceptive use by male participants should be consistent with local regulations.
6. 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.

Exclude criteria

1. Has presence of cirrhosis on liver biopsy
2. Has Type 1 diabetes
3. 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
4. Has a history of bariatric surgery <=5 years before study participation
5. Has undergone a major surgical procedure <=3 months before study participation or has major surgery planned during the study
6. 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.
7. 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

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT04583423