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COVID-19 Contingency

The safety of our study participants and study staff is our number one priority, especially during these changing times. We are staying on top of the latest COVID-19 developments and working to deploy ways to maintain the safety of everyone involved, while keeping the study on track. Participants are encouraged to contact their study site directly for the latest updates or with any questions or concerns.

We stay dedicated.

We remain committed to finding an effective and well tolerated treatment for this serious liver disease that impacts millions around the world.

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

Today, more than ever, our health must be a top priority. NASH is a progressive, chronic liver disease; it can put you at risk of liver failure, liver cancer, and even death. Having a compromised liver can also increase your risk of exposure to outside infectants. Understanding and learning how to effectively treat this common but serious liver disease will have a life-changing impact on many around the globe.

Obeticholic Acid (OCA) is being evaluated in the REGENERATE Study to treat liver fibrosis due to NASH. Thanks to the dedication and generosity of the patients and clinicians in this study, we have accomplished much, showing positive results at the 18-month interim analysis. The study remains ongoing to evaluate the safety and efficacy of OCA, and continued engagement and participation have never been more important.

We’ve completed enrollment.

Thanks to the personal contribution and dedication of our patients, as well as that of the clinicians and support staff, we are closer than ever to finding a treatment for this chronic and life-threatening condition.

What is NASH?

Nonalcoholic Steatohepatitis (NASH) is a chronic condition in which the buildup of fat, liver cell injury, and inflammation in the liver may eventually lead to liver scarring (also called liver fibrosis) which may advance and require a liver transplant. It is currently the second leading cause of liver transplant in the U.S.

Because people with NASH experience nonspecific symptoms, the disease can progress for years without a diagnosis.

With continued high rates of adult obesity and type 2 diabetes, more people each year develop this serious liver disease. Some believe this epidemic is expected to grow to 27 million cases in the U.S. by 2030.

Projected Growth of NASH
in the United States

Projected Growth of NASH in the United States

2015 16.5M patients

2030 27M patients

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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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