A Study to Evaluate the Safety and Effectiveness of Obeticholic Acid Treatment on People with Non-Alcoholic Steatohepatitis with Fibrosis

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-000403
    NCT ID: NCT02548351
    Sponsor Protocol Number: 747-303

About this study

The primary objectives of this study are to evaluate the safety and effectiveness of obeticholic acid treatment compared to placebo on both tissue structure improvement and 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histologic evidence of Nonalcoholic Steatohepatitis following a liver biopsy obtained no more than 6 months before day 1
  • Histologic evidence of fibrosis stage 1, 2 or 3
  • Is either not taking or is on stable doses of
    • TZDs or vitamin E
    • Therapies for diabetes
    • Allowed concomitant medications
  • Stable body weight
  • Age ≥18 years
  • Female subjects of childbearing potential must use ≥1 effective method of contraception during the study and until 4 weeks following the last dose of investigational product or at study termination
  • Must provide written informed consent and agree to comply with the study protocol

Exclusion Criteria

  • Current or history of significant alcohol consumption
  • Prior or planned (during the study period) bariatric surgery or ileal resection
  • HbA1c ≥9.0% within 60 days before day 1
  • Evidence of other forms of chronic liver disease including
    • Positive test result for hepatitis B surface antigen or hepatitis C antibody
    • Primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndrome
    • Alcoholic liver disease
    • Wilson's disease, hemochromatosis, or iron overload
    • Alpha-1-antitrypsin (A1AT) deficiency
    • Prior known drug-induced liver injury
    • Known or suspected HCC
    • History of liver transplant, current placement on a liver transplant list, or current MELD score >12
  • Histological presence of cirrhosis
  • Total bilirubin >1.5 mg/dL
  • AST >10× ULN, international normalized ratio (INR) >1.3 or serum creatinine ≥1.5 mg/dL
  • Creatinine Phospho Kinase > 5xULN
  • Platelet count <100,000/mm3
  • LDL ≥190mg/dL and already on statin therapy
  • Inability to safely undergo a liver biopsy
  • History of biliary diversion
  • Known positivity for human immunodeficiency virus infection
  • Recent history of specific types of cardiovascular disease
  • Other medical conditions that may diminish life expectancy to < 2 years, including known cancers
  • Known substance abuse
  • Pregnancy, planned pregnancy, potential for pregnancy or current or planned breast feeding
  • Participated in a clinical research study with any investigational product being evaluated for the treatment of diabetes, weight loss, or NASH in the 6 months before day 1
  • Received any investigational product not being evaluated for the treatment of diabetes, weight loss, or NASH within 30 days before day 1
  • Previous exposure to Obeticholic Acid
  • Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
  • History of known or suspected clinically significant hypersensitivity to Obeticholic Acid or any of its components
  • Any other condition that, in the opinion of the Investigator, would impede compliance or hinder completion of the study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elizabeth Carey, M.D.

Open for enrollment

Contact information:

Debra Ryan CCRP

(480)342-1208

Ryan.Debra29@mayo.edu

.
CLS-20318086

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