Although millions of people are living with NASH, there are no medications approved to treat the disease. The REGENERATE study is evaluating an investigational medication called obeticholic acid (OCA) for the treatment of NASH with liver fibrosis in adults. OCA is a man-made version of a natural compound found in the liver called a bile acid that is involved with digestion and liver function. OCA has not been approved for NASH and liver fibrosis in any country. Safety and efficacy have not been established.
A previous Phase II trial conducted by the National Institutes of Health studied OCA in NASH. REGENERATE is a Phase III trial, meaning the investigational medication is given to large groups of people (300 to 3,000) after studies in smaller groups of patients.
The goal of the REGENERATE study is to evaluate the safety and efficacy of an investigational medication, OCA, in adult patients with NASH and liver scarring (fibrosis) without cirrhosis.
Study participants take a pill every day and go in for regular study visits. They receive OCA or a placebo, a pill that has no medical effect. Neither patient nor doctor know which group the patient is assigned to.
The trial period is approximately seven years. Participants are evaluated by the study team after the first month of treatment and once every three months for the first year and a half. After that, participants are seen every six months.
Use ClinTrialConnect to learn more about NASH and the REGENERATE study, communicate with study sites, and download and share resources with loved ones.