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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT04171765

Run by

Genentech, Inc.

People needed

46

Starts

2020-09-30

Expected to finish

2023-01-23

Last updated by the study team

2024-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• National Research Institute - Panorama City — Santa Monica, California, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Excel Medical Research — Boca Raton, Florida, United States
• Premier Research Associate, Inc — Miami, Florida, United States
• Covenant Research — Sarasota, Florida, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Grand Teton Research Group, PLLC — Idaho Falls, Idaho, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Avant Research Associates, LLC — Crowley, Louisiana, United States
• Walter Reed Army Medical Center — Bethesda, Maryland, United States
• Huron Gastroenterology Associates — Ypsilanti, Michigan, United States
• Kansas City Research Institute, LLC — Kansas City, Missouri, United States
• Amici Clinical Research — Raritan, New Jersey, United States
• Duke Medical Center; Gen Clinic Research Ctr — Durham, North Carolina, United States
• Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department — Columbus, Ohio, United States
• Cullman Clinical Trials — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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