Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

  • sponsor
    Intercept Pharma
Updated on 23 November 2020


Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)


To study the investigational drug, obeticholic acid (also known as OCA), and its effect on NASH and to find out how safe and effective OCA may be in delaying specific medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis.

Patients will need to complete 1 or 2 screening visits to see if they are eligible to participate in the study. If eligible, patients will be asked to come back to the clinic 8 times and then every 3 months for the first 18 months they are in the study and then 2 times per year (every 6 months) for each additional year they are in the study. Participation in the study is expected to last for approximately up to 6 years but could be shorter.

Estimated Enrollment: 2000
Study Start Date: September 2015
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021

Condition Liver Disease, Gastrointestinal Diseases and Disorders
Clinical Study IdentifierTX142647
SponsorIntercept Pharma
Last Modified on23 November 2020


Yes No Not Sure

Inclusion Criteria

Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1
Histologic evidence of fibrosis stage 2 or 3, or fibrosis stage 1a or 1b if accompanied by obesity, Type 2 diabetes or ALT >1.5× ULN
Not taking or on stable dose of TZDs or vitamin E (6 months), therapies for diabetes and weight loss (90 days), other meds (30 days)
Stable body weight for at least 3 months
Age ≥18 years
Female subjects of childbearing potential must use contraception
Must provide written informed consent and agree to comply with the study protocol

Exclusion Criteria

Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before Screening
Prior or planned bariatric surgery or ileal resection
HbA1c ≥9.0% within 60 days before Day 1
Evidence of other forms of chronic liver disease
Histological presence of cirrhosis
LDL ≥190 mg/dL and already on a stable dose of statin therapy
Inability to safely undergo a liver biopsy
History of biliary diversion
Known to be HIV+
Recent history atherosclerotic cardiovascular disease
Known substance abuse in the year before Screening
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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