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

Phase 2TerminatedNCT04171765

Genentech, Inc.46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-alcoholic Steatohepatitis

Interventions

PlaceboDRUG

Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.

BFKB8488ADRUG

Participants will receive subcutaneous (SC) BFKB8488A.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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 Exclusion Criteria * 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 (53)

Outcomes

Primary Outcomes

Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at 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.

Time frame: Week 52

Secondary Outcomes

Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52

Time frame: Baseline, Week 16, Week 52

Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52

Time frame: Week 52

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

Time frame: Week 52

Data from ClinicalTrials.gov

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