A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis

• Status: Recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

Inclusion Criteria

• Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3

• Hepatic steatosis on MRI (>= 8% average PDFF) prior to randomization

Exclusion Criteria

• History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C

• Weight gain > 10% or loss > 5% within 3 months prior to randomization

• History of liver transplantation

• Current or history of significant alcohol consumption