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

NCT04171765 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-04-16

Study results available
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Summary

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

Conditions

  • Non-alcoholic Steatohepatitis

Interventions

DRUG

Placebo

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

DRUG

BFKB8488A

Participants will receive subcutaneous (SC) BFKB8488A.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2023-01-23
Completion
2023-01-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171765 on ClinicalTrials.gov