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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 89bio Ltd.; 89bio, Inc.
• Collaborators: ProSciento; ProSciento, Inc.

Criteria

Key Inclusion Criteria:

• Subjects must be 21 to 75 years of age inclusive, at the time of signing the informed consent form (ICF).

• Evidence of steatosis by Fibroscan and MRI-PDFF

• NASH or NAFLD at high risk for NASH as reflected by AT LEAST ONE of the following:

• Diagnosis of NASH with fibrosis (stages F1, F2 or F3), without cirrhosis, by percutaneous liver biopsy within 24 months prior to screening

• Central obesity WITH T2DM

• Central obesity WITH either increased ALT and/or Fibroscan VCTE score ≥7 KPa.

• Part 2 only: Biopsy-proven NASH in a liver biopsy obtained within 24 weeks of baseline 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. A small number of high risk F1 allowed.

Key Exclusion Criteria:

• Clinically significant disorder or a history of any illness that, in the opinion of the Investigator, might confound the results of the study, or pose additional risk to the subject by participation in the study.

• History of type 1 diabetes.

• Weight loss of more than 5% within 3 months prior to Day -1 or more than 10% within 6 months prior to Day -1 or planning to try to lose weight during conduct of study.

• History of a liver disorder other than NASH or clinical suspicion of a liver disorder other than NASH

• History of cirrhosis or evidence of cirrhosis