Randomized Global Phase 3 Study to Evaluate the Impact of Obeticholic Acid Treatment on Nonalcoholic Steatohepatitis Patients

Overview

About this study

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
  • Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
  • Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥ 1 of the following risk factors:
    • Obesity (BMI ≥ 30 kg/m^2);
    • Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria;
    • ALT >1.5 × upper limit of normal (ULN).
  • For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
  • Stable body weight.
  • Age ≥18 years.
  • Female subjects of childbearing potential must use ≥ 1 effective method of contraception during the study and until 30 days following the last dose of investigational product. Effective methods of contraception are considered to be those listed below:
    • Barrier method; i.e., condom (male or female) with spermicide or diaphragm with spermicide;
    • Intrauterine device;
    • Vasectomy (partner);
    • Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection);
    • Abstinence (defined as refraining from heterosexual intercourse).
  • Must provide written informed consent and agree to comply with the study protocol.

Exclusion Criteria:

  • Model for End-stage Liver Disease (MELD) score > 12.
  • ALT ≥ 10 × ULN.
  • HbA1c > 9.5%.
  • Total bilirubin > 1.5 mg/dL.
  • Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
  • History of liver transplant, or current placement on a liver transplant list.
  • Current or history of significant alcohol consumption.
  • Prior or planned ileal resection, or prior or planned bariatric surgery.
  • Histological presence of cirrhosis.
  • History of biliary diversion.
  • Known positivity for human immunodeficiency virus infection.
  • Acute cholecystitis or acute biliary obstruction.
  • BMI > 45 kg/m^2.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kymberly Watt, M.D.

Closed for enrollment

Contact information:

Brittany Price

(507)266-8725

Price.Brittany@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20178018

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