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

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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)

NCT04929483•89bio, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 21 to 75
•Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System 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

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

Locations (89)

89bio Clinical Study Site

Birmingham, Alabama, United States

89bio Clinical Study Site

Birmingham, Alabama, United States

89bio Clinical Study Site

Dothan, Alabama, United States

89bio Clinical Study Site

Guntersville, Alabama, United States

89bio Clinical Study Site

Madison, Alabama, United States

89bio Clinical Study Site

Chandler, Arizona, United States

89bio Clinical Study Site

Glendale, Arizona, United States

89bio Clinical Study Site

Peoria, Arizona, United States

89bio Clinical Study Site

Tucson, Arizona, United States

89bio Clinical Study Site

Tucson, Arizona, United States

Key Dates

Start Date

June 4, 2021

Primary Completion Date

February 14, 2023

Completion Date

October 8, 2024

Last Updated

January 6, 2026

Enrollment

222

ACTUAL participants

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

BIO89-100

DRUG

Placebo

DRUG

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NCT03587831

NASH - Nonalcoholic Steatohepatitis

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Hepatic Energy Fluxes in NASH and NAS Patients

NCT03997422

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Hepatic Energy Fluxes in NASH and NAS Patients

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