CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 222 enrolled
Drug / intervention
BIO89-100 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04929483
NCT04929483Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BIO89-100 in Subjects With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)

89bio, Inc.·interventional·Posted Jun 18, 2021·Updated Jan 6, 2026

In Brief

A Phase 2 clinical trial evaluating BIO89-100 and Placebo for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 222 participants across 89 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 18, 2021
Enrollment StartJun 4, 2021
Primary CompletionFeb 14, 2023
Study CompletionOct 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.0 years ago

Interventions

BIO89-100drug

Subcutaneous injection

Placebodrug

Subcutaneous injection