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PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

NCT05022693•89bio, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 21 to 65
•Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.
•Model for End-Stage Liver Disease (MELD) score \< 12.
•Child-Turcotte-Pugh (CTP) score \< 7 (Class A).
•Fibrosis stage F4 by FibroScan.

Exclusion Criteria

•History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.
•Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.
•known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.
•Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.

Locations (1)

89bio Clinical Study Site

Chandler, Arizona, United States

Key Dates

Start Date

August 16, 2021

Primary Completion Date

December 21, 2021

Completion Date

December 21, 2021

Last Updated

March 2, 2022

Enrollment

ACTUAL participants

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

BIO89-100

DRUG

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Hepatic Energy Fluxes in NASH and NAS Patients

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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: March 2, 2022Data 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

PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

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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