AstraZeneca
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
Study details include: * The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks. * The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks. Disclosure Statement: This is a parallel group treatment study that is blinded to the participants and investigators. Number of Participants: Approximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approxi…
Key Inclusion Criteria: * Males/females aged 18 or over * A diagnosis of SLD with advanced fibrosis * No significant change in weight over the last 6 months * Contraceptive us by participants or participants partners * Capable of giving informed consent * Judged by the investigator to be suitable for study Key Exclusion Criteria: * Portal hypertension (LSM \>25 kPa or 20-25 kPa with platelets \<150×10⁹/L), decompensated liver disease, Child-Pugh \>A6, MELD \>12, other chronic liver diseases, prior/planned liver transplant, or malignant liver tumors. * Positive viral infections, including HI…
potent, selective, first-in-class, small molecule oral inhibitor of FAP and is being developed for the treatment of CLDs with advanced hepatic fibrosis including cirrhosis.
Oral administration