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

NCT05809934

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Nonalcoholic Steatohepatitis

Interventions: AZD2693, Placebo

Countries: United States, Argentina, Brazil, Chile, China, Colombia, Germany, Hong Kong

A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria :

Participants are eligible to be included in the study only if all the following criteria apply:

Age

1. Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.

Type of Participant and Disease Characteristics
2. Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
3. 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:

1. Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).

1. Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.

Key Exclusion Criteria :

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

Medical Conditions

1. 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)
2. History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
3. 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).
4. Confirmed platelet count outside the normal range at the screening visit.
5. Any of the following confirmed at the screening visit:

1. ALT \> 5.0 × ULN
2. TBL \> 1.5 mg/dL (TBL \> 1.5 mg/dL is allowed if conjugated bilirubin is \< 1.5 × ULN)
3. INR \> 1.3
4. ALP \> 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)

Locations (164)

Chandler, Arizona, United States
Peoria, Arizona, United States
Surprise, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Gardena, California, United States
La Mesa, California, United States
Lancaster, California, United States
Los Angeles, California, United States
Montclair, California, United States
Orange, California, United States
Rialto, California, United States
Santa Ana, California, United States
Boca Raton, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Port Orange, Florida, United States
Winter Park, Florida, United States
Marietta, Georgia, United States
Topeka, Kansas, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Westlake, Ohio, United States
Chickasha, Oklahoma, United States
Hershey, Pennsylvania, United States
Summerville, South Carolina, United States
Cordova, Tennessee, United States
Austin, Texas, United States
Brownsville, Texas, United States
Denison, Texas, United States
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