Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
A legfontosabb adatok
- Hol
- Austin, Chandler, Clarksville, Denison, Fresno, Georgetown, Houston, Jupiter, Kansas City, Las Vegas, Miami, Morehead City, Port Orange, Raleigh, San Antonio, St Louis, Tucson, Westlake és Yukon (Egyesült Államok)Mind a 19 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Austin, TexasHospital not named in the registryRésztvevőt keres
- Chandler, ArizonaHospital not named in the registryRésztvevőt keres
- Clarksville, TennesseeHospital not named in the registryRésztvevőt keres
- Denison, TexasHospital not named in the registryRésztvevőt keres
- Fresno, CaliforniaHospital not named in the registryRésztvevőt keres
- Georgetown, TexasHospital not named in the registryRésztvevőt keres
- Houston, TexasHospital not named in the registryRésztvevőt keres
- Jupiter, FloridaHospital not named in the registryRésztvevőt keres
- Kansas City, MissouriHospital not named in the registryRésztvevőt keres
- Las Vegas, NevadaHospital not named in the registryRésztvevőt keres
- Miami, FloridaHospital not named in the registryRésztvevőt keres
- Morehead City, North CarolinaHospital not named in the registryRésztvevőt keres
- Port Orange, FloridaHospital not named in the registryRésztvevőt keres
- Raleigh, North CarolinaHospital not named in the registryRésztvevőt keres
- San Antonio, TexasHospital not named in the registryRésztvevőt keres
- St Louis, MissouriHospital not named in the registryRésztvevőt keres
- Tucson, ArizonaHospital not named in the registryRésztvevőt keres
- Westlake, OhioHospital not named in the registryRésztvevőt keres
- Yukon, OklahomaHospital not named in the registryRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- AstraZeneca
- Azonosító
- NCT07610837
- A regiszteradat frissítve
- 2026. november 3.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.