AK-US-001-0105
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) AND FIBROSIS
IRAS ID
1008036
Contact name
Chris Ayscue-Tse
Contact email
Sponsor organisation
Akero Therapeutics, Inc.
Research summary
This study is taking place in 260 sites worldwide with 1000 patients being enroled. Nonalcoholic steatohepatitis (NASH) is the most severe form of nonalcoholic fatty liver disease (NAFLD), making it a global health burden. This is characterised by excessive accumulation of fat in the liver and inflammation. Although there are no presenting symptoms of NAFLD, symptoms may include fatigue and mild jaundice. There are no approved therapies for the treatment of NASH. The current standard of care is weight loss through lifestyle modifications. Although diet and exercise are effective in maintaining the symptoms of NASH, adhering to a modified lifestyle is quite poor, highlighting the unmet need to develop therapies that slow or halt the progression of NASH. The purpose of this study is see if study treatment, Exfruxifermin (EFX) is effective in treating NASH by improving energy metabolism in the liver and mitigating inflammation. Participants must provide written consent prior to undergoing study procedures. After Screening assessments, eligible participants will be randomly assigned to 1 of 3 treatment groups; a placebo group, an experimental group that will receive EFX, 28mg and an experimental group that will receive EFX, 50 mg. All treatment groups will receive subcutaneous injections once weekly. The study is anticipated to last 112 weeks, including a 12-week screening period, 96-week treatment period and a 30-day follow up visit. After Screening, site visits for safety and disease-related assessments will be performed for up to 96 weeks. Participants are required to return to study site 30 days after last dose of study treatment. This study includes blood sampling and a Dual-energy X-ray Absorptiometry (DXA) scan. An external Data Monitoring Committee (DMC) will review the progress of the study. Participant's true study duration may be longer or shorter due to deviance from assumptions on participant enrolment and other aspects of study conduct.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0713
Date of REC Opinion
21 Dec 2023
REC opinion
Further Information Favourable Opinion