NCT04929483

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: 89bio, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	BIO89-100	Subcutaneous injection
DRUG	Placebo	Subcutaneous injection

Timeline

• Start date: 2021-06-04
• Primary completion: 2023-02-14
• Completion: 2024-10-08
• First posted: 2021-06-18
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

89 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study