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

Phase 2

Terminated

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: Placebo; Drug: BFKB8488A

• Registration Number: NCT04171765
• Lead Sponsor: Genentech, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-09-30
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-23
• Results First Submitted: 2024-01-19
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Results First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive a fixed dose of placebo matched to BFKB8488A.
Fixed Dose: BFKB8488A Dose A	BFKB8488A	Participants will receive BFKB8488A.
Fixed Dose: BFKB8488A Dose B	BFKB8488A	Participants will receive BFKB8488A.
Fixed Dose: BFKB8488A Dose C	BFKB8488A	Participants will receive BFKB8488A.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52	Week 52	Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52	Week 52
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52	Baseline, Week 16, Week 52
Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52	Week 52

Trial Locations

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

Scroll for more (43 remaining)