Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
← catalyst calendarNCT07610837 · readout in 322 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
104estimated
Sites
20
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-07 | actual | When the study began enrolling |
| Primary completion | 2027-07-07 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-07 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Liver Fibrosis
- Hepatic Cirrhosis
Interventions
- Drug: AZD2389 — also filed as Active IMP
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFAbsolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
measured 24 weeks
Reported quantity and severity of adverse events (AEs)
measured Up to and including Day 197
Number of participants with observed changes in blood pressure against baseline mmHg value
measured Up to and including Day 197
Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG)
measured Up to and including Day 197
Number of participants with abnormal laboratory results detected in urine samples
measured Up to and including Day 197
Number of participants with observed changes in heart rate (BPM) against baseline value
measured Up to and including Day 197
Number of participants with observed changes in Sp02 oxygen values against baseline measurement
measured Up to and including Day 197
Number of participants with observed changes in body temperature against baseline value
measured Up to and including Day 197
Number of participants with observed changes in respiratory rate against baseline value
measured Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
measured Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
measured Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
measured Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
measured Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
measured Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
measured Up to and including Day 197
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