Overview

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.