Overview

A Multiple Ascending Dose Study of BIO89-100 in Subjects With Biopsy Confirmed NASH or NAFLD and at High Risk of NASH

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

Part 1: This is a multi-center evaluation of BIO89-100 (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in subjects with NASH and NAFLD at high risk of NASH, including a pre-defined number of subjects with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled Part 2: This is a multi-center, open label evaluation of BIO89-100 at 27 mg administered weekly for 20 weeks in subjects with biopsy-poven NASH (NAS ≥4, fibrosis stage F2 or F3)

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

89bio Ltd.
89bio, Inc.

Collaborators:

ProSciento
ProSciento, Inc.