Loading clinical trials...

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis

A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

NCT04171765•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
•Hepatic steatosis on MRI (\>= 8% average PDFF) prior to randomization

Exclusion Criteria

•History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C
•Weight gain \> 10% or loss \> 5% within 3 months prior to randomization
•History of liver transplantation
•Current or history of significant alcohol consumption

Locations (53)

Cullman Clinical Trials

Cullman, Alabama, United States

Arizona Liver Health - Chandler

Chandler, Arizona, United States

Arizona Liver Health - Tucson

Tucson, Arizona, United States

Orange Grove Family Practice

Tucson, Arizona, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Gregory Wiener, MD

Chula Vista, California, United States

Community Cancer Institute (CCI)

Fresno, California, United States

National Research Inst.

Los Angeles, California, United States

Conquest Clinical Research

Orange, California, United States

UC San Diego Airway Research and Clinical Trials Center

San Diego, California, United States

Key Dates

Start Date

September 30, 2020

Primary Completion Date

January 23, 2023

Completion Date

January 23, 2023

Last Updated

April 16, 2024

Enrollment

ACTUAL participants

Conditions

Non-alcoholic Steatohepatitis

Interventions

Placebo

DRUG

BFKB8488A

DRUG

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

View study

RECRUITINGNA

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

NCT06661655

Metabolic Syndrome XFatty Liver+5 more

View study

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: April 16, 2024Data 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

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

CHronic Hepatopathies Associated with ALcohol Consumption and MetAbolic Syndrome

Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis

Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)