The ENLIGHTEN-Cirrhosis Study
Research type
Research Study
Full title
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
IRAS ID
1010199
Contact name
Margaret Nguyen
Contact email
Sponsor organisation
89bio, Inc
Clinicaltrials.gov Identifier
Research summary
Metabolic Dysfunction Associated Steatohepatitis (MASH) is chronic liver disease, characterised by the liver having too much fat. This can cause damage like liver scarring (known as fibrosis), or extreme scarring (cirrhosis). Despite the seriousness of disease there are currently no approved therapies for treatment of MASH with compensated cirrhosis. Pegozafermin is the “investigational” medicine being used and has not yet been approved for marketing by the 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, double-blind, placebo-controlled study of pegozafermin for the treatment of liver fibrosis stage F4 in adult subjects with compensated cirrhosis due to MASH. The study is designed to assess the efficacy and safety of pegozafermin, administered weekly in subjects with compensated cirrhosis (stage F4 biopsy-confirmed) MASH. The study population will be males or females, aged 18 to 75 years. Approximately 762 participants will be randomly assigned to one of two dose groups who will receive weekly injections of Pegozafermin (n=381) or placebo (n=381). The total study duration is estimated to be minimally 64 months. It will consist of a screening period of up to 12 weeks, a 60-month treatment period (minimally) (actual treatment duration will vary depending on the time to accrue the number of adjudicated events and a follow-up period. 89bio, Inc. is the Sponsor that will be responsible for funding the research of this trial.
REC name
Wales REC 5
REC reference
24/WA/0219
Date of REC Opinion
11 Sep 2024
REC opinion
Further Information Favourable Opinion