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

Summary

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.

Timeline

Start

2020-11-11

Primary completion

2023-04-13

Completion

2023-04-13

Publications

• Results Raji A, Gantz I, Crutchlow M, Flynn H, Xu L, Rodgers AJ, Krishnan R, Rizk ML, Hu S, Kaufman KD, Engel SS; MK-3655 P001 Study Group. Clinical Trial: A Phase 2b Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-Cirrhotic MASH. Aliment Pharmacol Ther. 2025 Apr;61(7):1152-1162. doi: 10.1111/apt.70038. Epub 2025 Feb 21.

Drugs

Indications