A Study to Evaluate AZD2693 in patients carriers of the PNPLA3 148M Risk Allele with non-cirrhotic non-alcoholic steatohepatitis with fibrosis

JRCT ID: jRCT2041220155

Registered date:03/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nonalcoholic Steatohepatitis
• Date of first enrollment: 08/03/2023
• Target sample size: 232
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Chile,Japan,China,Japan,Colombia,Japan,Germany,Japan,Hong Kong,Japan,India,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Peru,Japan,Philippines,Japan,Portugal,Japan,Spain,Japan,Singapore,Japan,South Korea,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United States of America,Japan,Vietnam,Japan
• Study type: Interventional
• Intervention(s): AZD2693 (Placebo) solution SC once per month

Outcome(s)

• Primary Outcome: Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology at Week 52

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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

2. Participants who are carriers for the PNPLA3 rs738409 148M risk allele, who have either homozygous or heterozygous G/G or G/C genotypes.

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:

(a) Definitive NASH with NAS greater than or equal to 4 with greater than or equal to1 in each component (ie, steatosis, lobular inflammation, and ballooning).

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

Exclude criteria

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:

(a) ALT > 5.0 x ULN

(b) TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 x ULN)

(c) INR > 1.3

(d) ALP > 1.5 x ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05809934