Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
Key facts
- Where
- Austin, Chandler, Clarksville, Denison, Fresno, Georgetown, Houston, Jupiter, Kansas City, Las Vegas, Miami, Morehead City, Port Orange, Raleigh, San Antonio, St Louis, Tucson, Westlake, and Yukon, United StatesSee the 19 sites
- Phase
- Phase 2
Where in United States
- Austin, TexasHospital not named in the registryTaking people
- Chandler, ArizonaHospital not named in the registryTaking people
- Clarksville, TennesseeHospital not named in the registryTaking people
- Denison, TexasHospital not named in the registryTaking people
- Fresno, CaliforniaHospital not named in the registryTaking people
- Georgetown, TexasHospital not named in the registryTaking people
- Houston, TexasHospital not named in the registryTaking people
- Jupiter, FloridaHospital not named in the registryTaking people
- Kansas City, MissouriHospital not named in the registryTaking people
- Las Vegas, NevadaHospital not named in the registryTaking people
- Miami, FloridaHospital not named in the registryTaking people
- Morehead City, North CarolinaHospital not named in the registryTaking people
- Port Orange, FloridaHospital not named in the registryTaking people
- Raleigh, North CarolinaHospital not named in the registryTaking people
- San Antonio, TexasHospital not named in the registryTaking people
- St Louis, MissouriHospital not named in the registryTaking people
- Tucson, ArizonaHospital not named in the registryTaking people
- Westlake, OhioHospital not named in the registryTaking people
- Yukon, OklahomaHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07610837
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)
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.
Inclusion: 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.
Exclusion: Alcohol intake above protocol thresholds, or positive screen for drugs of abuse; Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment; 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; 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; Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT/AST), recent participation in another IMP study, or investigator judgment of unsuitability.