IVA_01_337_HNAS_16_002
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multicenter, dose-range, proof-of-concept, 24-week treatment study of IVA337 in adult subjects with nonalcoholic steatohepatitis (NASH)
IRAS ID
215166
Contact name
Quentin Anstee
Contact email
Sponsor organisation
Inventiva S.A.
Eudract number
2016-001979-70
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. It is characterized on liver microscopy by the accumulation of fat in liver cells, infiltration of the liver by inflammatory cells and signs of liver cell damage (swollen cells called ballooned cells) and can also show scar tissue formation (fibrosis). The disease is mostly associated with obesity and type 2 diabetes mellitus (or earlier stages of impairment of glucose level regulation, namely insulin resistance) and is therefore very common. Prevalence is increasing. IVA337, a panPPAR agonist, is a novel drug acting on insulin sensitivity, lipid metabolism and fibrotic processes. Animal studies have shown that IVA337 is able to prevent liver fibrosis progression or even reverse the process. Previous clinical studies in healthy volunteers and patients with type 2 diabetes have shown that IVA337 is well tolerated, improves insulin sensitivity, increases HDL-cholesterol (which is the beneficial type of cholesterol) and decreases triglycerides.
The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis. The study will involve 300 patients in several countries in Europe and Australia. During the study, the enrolled patients will undergo 6 periodic visits for a total duration of participation in the study of 7 to 8 months. Efficacy will be assessed by performing and analysing a liver biopsy at the end of the treatment using a histological score (SAF) and focusing on the inflammation and ballooning score changes. The safety of the drug will be assessed by recording adverse events and performing standard laboratory tests and electrocardiograms.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0363
Date of REC Opinion
8 Feb 2017
REC opinion
Further Information Favourable Opinion