Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD
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 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
  • National Research Institute - Panorama City accepting new patients
    Santa Monica California 90402 United States
  • Community Cancer Institute (CCI) accepting new patients
    Fresno California 93720 United States
  • National Research Inst. accepting new patients
    Los Angeles California 90057 United States
  • National Research Inst. not yet accepting patients
    Los Angeles California 90057 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