FASCINATE-3
Research type
Research Study
Full title
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of denifanstat in patients with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and F2/F3 fibrosis (FASCINATE-3)
IRAS ID
1010701
Contact name
Eduardo Martins
Contact email
Sponsor organisation
Sagimet Biosciences
Clinicaltrials.gov Identifier
Research summary
This study is taking place in 350 sites worldwide with 1260 patients being enrolled. Metabolic dysfunction-associated steatotic liver disease (MASLD) is one of the most prominent forms of chronic liver disease worldwide. Metabolic dysfunction-associated steatohepatitis (MASH) is a subset of MASLD which is associated with inflammation and hepatocyte injury. MASH/MASLD are associated with obesity, diabetes mellitus, high cholesterol, hypertriglyceridemia, high blood pressure, scarring of the liver, liver failure, and liver cancer. The purpose of this study is to see if study treatment, denifanstat, will help in the treatment of non-cirrhotic metabolic dysfunction associated steatohepatitis (MASH) and stage 2/stage 3 (F2/F3) fibrosis (liver scarring) and how safe it is to use in people. The first 900 participants will be randomly assigned to 1 of 3 treatment groups; a placebo group, an experimental group that will receive denifanstat, 25mg and an experimental group that will receive denifanstat, 50 mg. All treatment groups will receive an oral tablet once daily. There will be a review of the first 900 patients after 52 weeks of treatment to check whether the MASH has gone away or whether the fibrosis has improved. The next 360 participants will be randomly assigned to 1 of 2 treatment groups; a placebo group, an experimental group that will receive denifanstat, 50mg. Both treatment groups will receive an oral tablet once daily.
There will be a total of three study periods, as follows: Screening Period: up to 12 weeks (approximately 3 months), Double-Blind Treatment Duration: 234 weeks (approximately 4.5 years), Follow-up: 4 weeks after end of treatment visit (1 month). This study includes blood and urine sampling, physical examinations including vitals signs and ECGs, questionnaires, liver biopsies and MRI scan. An external Data Monitoring Committee (DMC) will review the progress of the study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0038
Date of REC Opinion
15 Apr 2025
REC opinion
Further Information Favourable Opinion