NCT07610837 Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
| NCT ID | NCT07610837 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Liver Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2027-07-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 104 participants in total. It began in 2026-05-07 with a primary completion date of 2027-07-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07610837 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07610837 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07610837 currently recruiting?
Yes, NCT07610837 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07610837 trial being conducted?
This trial is being conducted at Chandler, United States, Tucson, United States, Jupiter, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT07610837 clinical trial?
NCT07610837 is sponsored by AstraZeneca. The trial plans to enroll 104 participants.