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Clinical trials are an essential part of how drugs are developed and evaluated for human use. Participation may be an option to consider when no treatment
is available.

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

What is a clinical trial?

Clinical trials are research studies that investigate how safe and efficacious a medication is to prevent, treat, or cure a particular disease or condition. They are essential research tools for advancing medical knowledge and patient care.

Why join a clinical trial?

Participating in a clinical trial can have benefits. You may receive a medical treatment that is not available elsewhere. You could advance understanding of a disease and better the lives of others like you. Study-related medication and care is administered free of charge.

Clinical trials can also have risks. The investigational medication may not help you or it could have side effects. It’s possible 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. Being assigned to the placebo group may still produce benefit due to the overall care received while you are in the trial.

You should speak to your doctor to learn about the risks and benefits of any clinical trial before making the decision to participate in one.

What are the phases of clinical trials?

Clinical trial phase: Pre-Clinical
Pre-Clinical:

Drug compound
is first discovered and tested

Clinical trial phase: Phase I
Phase I:

Research begins
in healthy subjects

Clinical trial phase: Phase II
Phase II:

Studies involve patients with
the condition

Clinical trial phase: Phase III
Phase III:

Confirmation
of safety and efficacy in treating the condition in patients

Clinical trial phase: Phase IV
Phase IV:

Medication is approved for patient use and research continues

How do clinical trials work?

Every clinical trial has guidelines on who is eligible to participate. Study sponsor must provide a clear goal and structure of the trial. Investigational medications are often evaluated for safety and efficacy against a placebo (a pill that has no medical effect) or a different medication. Being assigned to the placebo group may still produce benefit due to the overall care received while you are in the trial. The length of a trial and the way testing is done is different for every trial.

How do clinical trials work? How do clinical trials work?

Patients taking placebo

Study doctor

Patients taking study drug

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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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