AZD2389 safety and dosing in adults with fatty liver disease and advanced liver scarring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, blinded Phase 2 trial comparing AZD2389 with placebo in adults with steatotic liver disease and advanced fibrosis. Participants will be assigned to AZD2389 or placebo for 24 weeks, with a 4-week screening and a 4-week follow-up, and visits roughly every 4 weeks (every 2 weeks early in the study). The study aims to characterize safety, tolerability, and pharmacodynamics, with approximately 104 participants randomized across two arms at three U.S. sites. The trial is parallel-group and blinded to both participants and investigators. Lead sponsor is AstraZeneca.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Chandler, Arizona, United States Recruiting
• Research Site
  Tucson, Arizona, United States Recruiting
• Research Site
  Fresno, California, 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

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.