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

A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis who are carriers of the PNPLA3 rs738409 148M Risk Allele - FORTUNA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041220155

Enrollment

232

Registered

2023-03-03

Start date

2023-03-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Steatohepatitis

Interventions

AZD2693 (Placebo) solution SC once per month

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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 5.0 x ULN (b) TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is 1.3 (d) ALP > 1.5 x ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology at Week 52	—

Countries

Argentina, Brazil, Chile, China, Colombia, Germany, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United States of America, Vietnam

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026