The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis.

Launched by ASTRAZENECA · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medicine called AZD2389 to see how it works in the liver of people with advanced liver fibrosis, which is a serious scarring of the liver often linked to liver cirrhosis. The study uses a special imaging technique called a PET scan to observe how the drug interacts with the liver. This is an early-stage (Phase 1) trial, mainly focused on understanding the drug’s effects and safety in the liver.

People who might take part are adults aged 20 or older who have stable liver cirrhosis but are otherwise healthy enough to join the study. Women must not be pregnant and both men and women need to agree to use birth control. Participants should not have certain infections like hepatitis B, hepatitis C, or HIV, nor have had recent serious health problems or liver complications. During the study, participants will receive the drug and have PET scans to track its effect on the liver. The trial is currently recruiting, and anyone interested should discuss eligibility with the study team to see if it’s a good fit.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male or female (of non-childbearing potential) participant aged ≥ 20 years and willing and able to give written informed consent for participation in the trial.
• • 2. History confirming compensated liver cirrhosis.
• • 3. Females must have a negative pregnancy test.
• • 4. Barrier contraceptives use by males.
• Key Exclusion Criteria:
• • 1. A condition that would interfere with evaluation of the trial intervention, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the trial.
• • 2. Any clinically significant illness, medical or major surgical procedure or trauma prior randomization.
• • 3. Hepatitis B , hepatitis C and/or HIV infection.
• • 4. Significant elevations in liver blood test, MELD score \>12 and platelets \<140 x109/L g).
• • 5. eGFR) \< 60 ml/min/1.73m2.
• • 6. History of decompensated liver cirrhosis.
• • 7. Any participants with an aetiology of liver cirrhosis where the Investigator considers that PET signal uptake may be impacted.
• • 8. History of bleeding disorders and major bleeding risk.
• • 9. History of severe dermatological disorders or wound healing.
• • 10. Positive screening result for drugs of abuse or alcohol.