A Study in Participants With Non-cirrhotic NASH With Fibrosis

Launched by ASTRAZENECA · Nov 25, 2022

Keywords

ClinConnect Summary

A randomized, double blind, placebo-controlled, parallel-group, multicenter study including a maximum of approximately 90 randomized adult participants with biopsy-proven non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis (NAS ≥ 4, fibrosis stages F1, F2, F3). The study will be conducted at approximately 48 sites across approximately 9 countries.

During screening, the participants will be checked for eligibility and enrolled in the study. Following a 8-week screening period, approximately 90 participants will be randomized in a 1:1 ratio to once daily dosing of AZD4831 or pla...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent.
• 2. 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
• • 3. 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.
• Exclusion Criteria:
• • 1. 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).
• • 2. 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.
• • 3. 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.
• • 4. High dose vitamin E (\> 400 IU) unless on a stable dose within 6 months of screening.
• • 5. 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).
• • 6. Recent (within 6 months of screening) use of obeticholic acid or other therapy under investigation for NASH.