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Choosing to join a clinical trial is an important decision. Talk to your doctor to get answers to your questions.

Are you at risk?
REGENERATE NASH fibrosis study patient and participant REGENERATE NASH fibrosis study patient and participant
What is a clinical trial?

Clinical trials are studies of investigational medications that are still in the development phase, with the goal of evaluating how they work in patients with a specific health condition. Clinical trials examine how safe and effective the study medication may be in helping improve a patient’s health.

What is NASH?

NASH is a chronic condition in which the buildup of fat and inflammation in the liver may eventually lead to severe scarring called fibrosis. It is found in people who drink little or no alcohol. Patients with NASH typically experience no symptoms until the disease has caused advanced liver damage.

Who is at risk for NASH?

NASH occurs most often in people who have:
  Pre-diabetes or type 2 diabetes
  A history of being overweight or obese
  High cholesterol or high blood pressure

It is more common in Hispanics than other ethnic groups.

How do I know if I have NASH?

Routine blood tests may indicate damage to the liver. However, in order to determine if you have NASH, a liver biopsy is necessary.

What is a liver biopsy?

The most accurate way to diagnose NASH is with a liver biopsy. A liver biopsy is a common procedure in which a small sample of your liver is removed and examined under a microscope.

I have fatty liver disease. Can I join the trial?

NASH is a serious form of Nonalcoholic Fatty Liver Disease, or NAFLD. If your doctor says you have fatty liver disease, you may also have NASH. Find out more by talking to your doctor.

What is OCA?

Obeticholic acid (OCA) is an investigational compound currently being studied in patients with NASH and liver fibrosis.

What are the benefits and risks of joining a clinical trial?

By joining a clinical trial, you may have the opportunity to receive treatment that could improve your condition before it becomes widely available. You could advance understanding of a disease and better the lives of others like you.

However, some medications studied in clinical trials may not be helpful, or may have unwanted and/or potentially harmful effects.

If you join a clinical trial, you may receive a placebo instead of the study medication. A placebo is a pill or substance with no active ingredients, and is not expected to have any real medical effect.

Subject to local laws and regulations, participants may receive reimbursement for their time, travel and meal expenses.

Can I leave a clinical trial after it has begun?

Yes. You may leave a clinical trial at any time.

Additional Resources

Information on Liver Disease

American Liver Foundation www.LiverFoundation.org

Canadian Liver Foundation www.liver.ca

Information on Clinical Studies

MedLine Plus: Interactive patient education tutorial on clinical trials at the National Library of Medicine's MedLine Plus web site. www.nlm.nih.gov/medlineplus

European Medical Association (EMA)
www.ema.europa.eu

ClinicalTrials.gov:
A searchable registry of federally and privately supported clinical trials conducted in the United States and around the world. The identifier for this NASH study is: NCT02548351 www.ClinicalTrials.gov

ISRCTN Clinical Trial Registry www.isrctn.org

US Food and Drug Administration (FDA) www.fda.gov

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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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