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The REGENERATE study is a clinical trial of an investigational medication for patients with NASH and liver scarring known as fibrosis.

REGENERATE NASH fibrosis study patient and participant REGENERATE NASH fibrosis study patient and participant

Why are we studying NASH?

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.

How did we get here?

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.

How does this trial work?

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.

One pill a day One pill a day
a day
Doctor evaluations Doctor evaluations
6 years to complete trial 6 years to complete trial
Years 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?

Learn more about risk factors and options you may consider.

Are you at risk?
How did you find out about this study?

To connect with the study site, you must first register with ClinTrialConnect.

Use ClinTrialConnect to learn more about NASH and the REGENERATE study, communicate with study sites, and download and share resources with loved ones.

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