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 for NASH called obeticholic acid (OCA). 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.
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 (1,000 to 3,000) after studies in smaller groups of patients. Researchers are now seeking patients to join the REGENERATE study.
The goal of the REGENERATE study is to evaluate the safety and effectiveness of an investigational compound, OCA, in patients with NASH and liver scarring (fibrosis).
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 five to six 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.
Could REGENERATE be an option for you?
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