Study of AZD2389 safety, tolerability, and pharmacodynamics in adults with steatotic liver disease and advanced fibrosis - BRAVO

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 HIV or hepatitis B, or hepatitis C unless HCV RNA‑negative ≥12 weeks after treatment.
• - Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.
• - Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin‑treated T2DM, uncontrolled hypertension, recent major cardiac/cerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.
• - History of psychosis, bipolar disorder, recent major depression, or suicide attempt/ideation within 1 year.
• - Bleeding risk or wound‑healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.
• - Prohibited medications or hypersensitivities, including moderate/strong CYP3A4 or BCRP/OAT3 inhibitors/inducers, anticoagulants/antiplatelets (except aspirin ≤81 mg/day), or hypersensitivity to DPP4 inhibitors.
• - Other protocol‑defined exclusions, including significant abnormal labs (e.g., worsening ALT/AST), recent participation in another IMP study, or investigator judgment of unsuitability.