This study is currently not recruiting participants.

A Phase 3 Double-Blind Randomized Long-Term Placebo-Controlled Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis

Investigating the Safety and Effectiveness of an Investigational Medication for NASH with Liver Fibrosis

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to find out how safe and effective OCA may be in delaying specific medical conditions or health-related issues that can occur in patient with NASH and evidence of liver fibrosis.

Detailed description of study

The purpose of this study is to find out how safe and effective OCA may be in delaying specific medical conditions or health-related issues that can occur in patient with NASH and evidence of liver fibrosis.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nonalcoholic Steatohepatitis
  • Age: 100 years or below
  • Gender: All

The purpose of this study is to investigate how safe and effective an investigational medication may be in delaying certain medical conditions or health-related issues in patients with Non-Alcoholic Steatohepatitis (NASH) and liver fibrosis. NASH is a liver disease characterized by inflammation and damage caused by a buildup of fat in the liver, which can lead to fibrosis, or scarring of the liver tissue.

Participants in this study will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor the participants' health to determine the effects of the medication on delaying the progression of liver-related health issues.

  • Who can participate: Participants aged 18 years and older with a diagnosis of Non-Alcoholic Steatohepatitis (NASH) and liver fibrosis may be eligible for this study. Key eligibility factors include liver biopsy confirmation and stable medical conditions.
  • Study details: Participants will be assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1512208865

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