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A Nonabsorbable Ileal Apical Sodium-Dependent Bile Acid Transporter Inhibitor for Nonalcoholic Steatohepatitis — BRAVO-1  

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
Use of A4250, a Nonabsorbable Ileal Apical Sodium-Dependent Bile Acid Transporter Inhibitor for Nonalcoholic Steatohepatitis (BRAVO-1)

Clinical Trial Summary

The objective is to determine whether 24 weeks of treatment with A4250 will improve several clinically-relevant features of NASH compared to treatment with placebo.

Clinical Trial Description

BRAVO-1 is a multicenter, randomized, double-masked, placebo controlled trial of 24 weeks of treatment with ABST inhibitor A4250, 3 mg daily or placebo for patients with nonalcoholic fatty liver disease (NAFLD). Screening for eligibility and collection of baseline data will span up to 90 days after obtaining informed consent and registration. Eligible patients will be randomized to receive either ABST inhibitor A4250 (3 mg per day) or placebo for 24 weeks of treatment. The trial will evaluate whether treatment with ABST inhibitor A4250, 3 mg daily for 24 weeks compared to treatment with placebo, improves the severity of nonalcoholic fatty liver disease (NAFLD) as determined by linear regression of change in ALT of treatment group and baseline ALT. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Liver Diseases
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT03451279
Study type Interventional
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status Withdrawn
Phase Phase 2
Start date January 2017
Completion date July 2019
View Details
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