A Study in Participants With Non-cirrhotic NASH With Fibrosis

Korábbi kezelés

• Recent (within 3 months of randomization) use of drugs approved for weight loss (eg, orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as those drugs used off-label.
• Recent (within 6 months of screening) use of therapies associated with development of NAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines).
• Recent (within 6 months of screening) use of obeticholic acid or other therapy under investigation for NASH.

Más betegség

• Liver disease of other etiologies (eg, alcoholic steatohepatitis; drug-induced, viral, or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha 1 antitrypsin deficiency; Wilson's disease).
• History of excessive alcohol consumption, defined as an average weekly intake of > 21 drinks/week for males or > 14 drinks/week for females. One drink is equivalent to 14 g alcohol.

Egyéb

• High dose vitamin E (> 400 IU) unless on a stable dose within 6 months of screening.

• Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent.
• Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosed by liver biopsy (within 12 months prior screening, participants without historical biopsy should be willing to undergo a liver biopsy at screening) fulfilling all of the following criteria:
  • NAS ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation and ballooning
  • Presence of fibrosis F1, F2-F3
• One increased serum ALT measurement (ALT > ULN) at screening, and historical local serum ALT level (> ULN [41 U/L for men and 31 U/L for women] but < 300 U/L) on ≥ 1 occasion in the 6 months prior to screening.