Condition: Liver Fibrosis · Hepatic Cirrhosis · Sponsor: AstraZeneca
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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.
This description comes directly from the study's public registry record.
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Research Site | Chandler, Arizona, United States | Recruiting |
| Research Site | Tucson, Arizona, United States | Recruiting |
| Research Site | Jupiter, Florida, United States | Recruiting |
| Research Site | Miami, Florida, United States | Recruiting |
| Research Site | Port Orange, Florida, United States | Recruiting |
| Research Site | Kansas City, Missouri, United States | Recruiting |
| Research Site | St Louis, Missouri, United States | Recruiting |
| Research Site | Las Vegas, Nevada, United States | Recruiting |
| Research Site | Morehead City, North Carolina, United States | Recruiting |
| Research Site | Raleigh, North Carolina, United States | Recruiting |
| Research Site | Westlake, Ohio, United States | Recruiting |
| Research Site | Yukon, Oklahoma, United States | Recruiting |
+ 8 more locations — full list on the registry record.
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