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

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 64 weeks

Summary

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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 64 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 64 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Discontinuing Study Medication Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks
Secondary study objectives
Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks
Percentage of Participants With ≥2 Point Improvement in NAS With ≥1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-3655 50 mgExperimental Treatment1 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 mgExperimental Treatment1 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 mgExperimental Treatment1 Intervention
Following a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Following a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,305 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
186 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,620 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
900 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical Director, MDStudy DirectorMerck Sharp & Dohme LLC
80 Previous Clinical Trials
16,309 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
~36 spots leftby Dec 2025
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