Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Non-alcoholic Steatohepatitis Fatty Liver Non-alcoholic Fatty Liver Disease BFKB8488A Fixed Dose: BFKB8488A Dose A Fixed Dose: BFKB8488A Dose B Fixed Dose: BFKB8488A Dose C Individualized Dose: BFKB8488A

Eligibility

You can join if…

Open to people ages 18-75

  • 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 CAN'T join 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

Locations

  • UC San Diego Airway Research and Clinical Trials Center not yet accepting patients
    San Diego California 92103 United States
  • Gregory Wiener, MD accepting new patients
    Chula Vista California 91910 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04171765
Phase
Phase 2
Study Type
Interventional
Last Updated