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

Recruiting at 187 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Antihyperglycemic agents

Disqualifiers: Cirrhosis, Type 1 diabetes, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

183 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have Type 2 diabetes, your condition must be controlled by diet or stable doses of diabetes medications.

What is the purpose of this trial?

This trial is testing a new drug called MK-3655 to see if it can help people with a liver condition called NASH. The goal is to find out if the drug can reduce liver inflammation and fat buildup without making liver scarring worse. Researchers hope that at least one dose of MK-3655 will be effective.

Research Team

Medical Director, MD

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

Inclusion Criteria

A female participant is eligible to participate in the study if she is not pregnant or breastfeeding, and she does not have a menstrual cycle.

Has histological confirmation of NASH

The subject either has no history of Type 2 diabetes mellitus or a history of T2DM that has been controlled by diet or stable doses of antihyperglycemic agents.

Exclusion Criteria

Has presence of cirrhosis on liver biopsy

Has Type 1 diabetes

Has a history of bariatric surgery ≤5 years before study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Run-in

Participants receive placebo by SC injection to establish baseline

2 weeks

Treatment

Participants receive MK-3655 or placebo by SC injection every 4 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• MK-3655
• Placebo

Participant Groups

Group I: MK-3655 50 mg Experimental Treatment 1 Intervention

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.

Group II: MK-3655 300 mg Experimental Treatment 1 Intervention

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

Group III: MK-3655 100 mg Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University