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Monoclonal Antibodies

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

Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52

Summary

This trial is testing a new drug called BFKB8488A to see if it can help people with a liver disease called NASH by reducing liver inflammation and fat buildup.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Fixed Dose: BFKB8488A Dose CExperimental Treatment1 Intervention
Participants will receive BFKB8488A.
Group II: Fixed Dose: BFKB8488A Dose BExperimental Treatment1 Intervention
Participants will receive BFKB8488A.
Group III: Fixed Dose: BFKB8488A Dose AExperimental Treatment1 Intervention
Participants will receive BFKB8488A.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive a fixed dose of placebo matched to BFKB8488A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BFKB8488A
2017
Completed Phase 1
~240

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,564 Previous Clinical Trials
570,186 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
154 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
896,199 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
236 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~9 spots leftby Dec 2025
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