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

Genentech

Status and phase: Terminated; Phase 2

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: BFKB8488A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04171765

GC41033

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a fixed dose of placebo matched to BFKB8488A.

Treatment:

Drug: Placebo

Fixed Dose: BFKB8488A Dose A

Experimental group

Description:

Participants will receive BFKB8488A.

Treatment:

Drug: BFKB8488A

Fixed Dose: BFKB8488A Dose B

Experimental group

Description:

Participants will receive BFKB8488A.

Treatment:

Drug: BFKB8488A

Fixed Dose: BFKB8488A Dose C

Experimental group

Description:

Participants will receive BFKB8488A.

Treatment:

Drug: BFKB8488A