The ENLIGHTEN-Fibrosis Study
Research type
Research Study
Full title
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction Associated Steatohepatitis (MASH) and Fibrosis
IRAS ID
1009791
Contact name
Jyoti Chauhan
Contact email
Sponsor organisation
89bio, Inc
Clinicaltrials.gov Identifier
Research summary
Pegozafermin is the “investigational” medicine being used and has not yet been approved for marketing by the Medicines and Healthcare products Regulatory Agency (MHRA). Pegozafermin belongs to a class of drugs known as FGF21 analogues. FGF21 is a hormone that is naturally present in the human body and actively works on the metabolism of fats and glucose in the liver, fat tissue, and pancreas. Pegozafermin has been modified so that it can last longer in the human body than the natural FGF21 form, therefore, affecting the metabolism for a longer duration of time. Prior studies have shown that pegozafermin has the ability to lower blood triglycerides, improve markers of glycaemic control and decrease abnormal fat storage in the liver.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of pegozafermin for the treatment of liver fibrosis stage F2 or F3 in adult subjects with Metabolic Dysfunction Associated Steatohepatitis (MASH). The study is designed to assess the efficacy and safety of 2 dose regimens of pegozafermin, administered either weekly or once every 2 weeks in subjects with biopsy-confirmed MASH. Approximately 1050 subjects will be randomized 1:1:1 (pegozafermin 30 mg weekly [n=350]: pegozafermin 44 mg once every 2 weeks [n=350]: placebo [n=350]). To maintain double dummy treatment design, approximately half of placebo subjects (n=175) will receive weekly dosing, and the other half (n=175) will receive once every 2 weeks dosing. The study will consist of an approximately 12-week screening period, 36-month double-blind treatment period, and a safety follow-up period 3 weeks post end-of-treatment visit. Study participants may or may not benefit from their participation in this study. However, the results that are obtained from this study may benefit others in the future. 89bio, Inc. is the Sponsor that will be responsible for funding the research of this clinical study.
REC name
West of Scotland REC 1
REC reference
24/WS/0066
Date of REC Opinion
26 Jul 2024
REC opinion
Further Information Favourable Opinion