A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Más betegség

• Medical Conditions
• Liver disease of other aetiologies (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 cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.

Laborértékek

• Historical persistent or pre-existing renal disease marked by eGFR < 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines).
• Confirmed platelet count outside the normal range at the screening visit.
• Any of the following confirmed at the screening visit:
  • ALT > 5.0 × ULN
  • TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 × ULN)
  • INR > 1.3
  • ALP > 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)

Egyéb

• Participants are excluded from the study if any of the following criteria apply:

• Participants are eligible to be included in the study only if all the following criteria apply:
• Age
• Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.
  • Type of Participant and Disease Characteristics
• Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
• Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:
  • Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
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  • Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.