Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07610837 | Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis | PHASE2 | RECRUITING | 104 | — | — | May 7, 2026 | Jul 7, 2027 | May 28, 2026 | 19 | United States |
| NCT06750276 | A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis. | PHASE2 | COMPLETED | 40 | — | — | Dec 6, 2024 | Jul 28, 2025 | Aug 14, 2025 | 9 | United States, Puerto Rico +1 |
| NCT07069725 | 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. | PHASE1 | RECRUITING | 12 | — | — | May 26, 2025 | Jul 13, 2026 | Apr 27, 2026 | 2 | Sweden |
To evaluate the effects of AZD2389 versus placebo on improvement in ELF score. Lowered ELF scores would suggest better outcome. Note: ELF is not bounded, i.e. there are no minimum and maximum values
To assess the safety and tolerability of AZD2389 in participants with SLD and advanced fibrosis
Assess blood pressure level (with systolic and diastolic pressure) in mmHg
12-lead safety ECG (PR interval, QRS complex, ST interval, T wave)
Urinalysis - Paper chromatography
Pulse rate measured in beats per minute (BPM)
Sp02 oxygen saturations measured by percentage
Body temperature measured in degrees Celsius
Respiratory rate measured in respirations per minute
Hematology - Platelets (x10\^9/L)
Reporting frequency and severity of AEs based on qualifying symptoms, signs, abnormalities in measured values, or other diagnoses as identified by investigator
Physical examinations will include assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, musculoskeletal (including spine and extremities) and neurological symptoms (examination of the participants' feet to observe skin integrity, circulation, and presence of any neuropathy).
FibroScan (VCTE) ultrasound imaging will measure a participant's level of LSM (liver stiffness), CAP (amount of fat in the liver), and/or SSM (spleen stiffness).
To examine target FAP occupancy in the liver by AZD2389 as measured with \[68Ga\]Ga-FAPI-46 PET.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Doses of AZD2389 to be administered orally. |
| Arm B | PLACEBO_COMPARATOR | Doses of placebo to be administered orally. |
| Cohort A | OTHER | Participants with presumed MASH/NASH with fibrosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo. |
| Cohort B | OTHER | Participants with SLD with advanced fibrosis including compensated cirrhosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo. |
| Part A | OTHER | In Part A, eligible participants (screening Visit 1) will return to the trial site for pre-assessments, confirmation of eligibility criteria, blood sampling for FAP concentration analysis (at the trial site), and the first PET examination (screening Visit 2). The participants will perform the PET examination at the PET Centre using the radioligand \[68Ga\]Ga-FAPI-46. Depending on the results of the initial PET examination, participants of Part A may be invited to continue the trial in Part B. In such a case they will participate in a total of 3 PET examinations, not exceeding predefined radiation exposure limits. If they do not participate further, they will complete the trial with a follow-up visit (Visit 3, telephone call) 7 days (±2 days) after the PET examination. |
| Part B1 | EXPERIMENTAL | In Part B1, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand \[68Ga\]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days \[±2 days\]) and Visit 6 (30 days\[+7 days\]) will monitor for safety and follow-up of AEs. |
| Part B2 | EXPERIMENTAL | In Part B2, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand \[68Ga\]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days \[±2 days\]) and Visit 6 (30 days\[+7 days\]) will monitor for safety and follow-up of AEs. |
| Part B3 | EXPERIMENTAL | In Part B3, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand \[68Ga\]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days \[±2 days\]) and Visit 6 (30 days\[+7 days\]) will monitor for safety and follow-up of AEs. |
| Part C | EXPERIMENTAL | In Part C (optional), participants attend the trial site during Visit 1 (screening, Day-35 to Day-14) to undergo an eligibility check. At Visit 2, the first PET examination with radioligand will be performed at least 5 days before IMP administration. At Visit 3 (Day 1), participants receive a single dose AZD2389, then undergo a second PET examination using the radioligand on Day 2, along with blood sampling for PK analysis and FAP activity. At Visit 4 (Day 8 ±2 days), participants will be admitted to the trial site for a second single dose, then undergo a third PET examination using the radioligand on Day 9, along with blood sampling. At Visit 5 (7 days ±2 days after the PET examination on Visit 4) and Visit 6 (30 days \[+7 days\]) after the drug administration on Visit 4), follow-up visits at the trial site take place for safety monitoring and follow-up of any AEs. |
| Name | Type | Description |
|---|---|---|
| AZD2389 | DRUG | potent, selective, first-in-class, small molecule oral inhibitor of FAP and is being developed for the treatment of CLDs with advanced hepatic fibrosis including cirrhosis. |
| Placebo | OTHER | Oral administration |
| PET scan and radioligand | DIAGNOSTIC_TEST | PET scan and radioligand |
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 f...