Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.

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

Details

• Lead Sponsor: 89bio, Inc.

Criteria

Key Inclusion Criteria:

• Age 21 to 75

• Biopsy-confirmed NASH with fibrosis stage F2 or F3 and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation.

• Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period

• Have obvious signs of NASH based on a number of blood tests and scans completed by a Health Care Provider including the following:

• Evidence of steatosis (MRI-PDFF ≥8%)

• Increased metabolic risk; must have at least 2 of the following: Central obesity, Type 2 diabetes mellitus, increased fasting triglycerides, reduced fasting HDL-c

• FibroScan® score ≥8.5 kPa

Key Exclusion Criteria:

• Have poorly controlled high blood pressure

• Have type 1 diabetes or poorly controlled type 2 diabetes.

• History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation

• Are planning to try to lose weight during the conduct of the study.

• Have a BMI <25 kg/m2

Other inclusion and exclusion criteria may apply.