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Study of AZD2389 for Steatotic Liver Disease with Advanced Fibrosis

This study is testing a new oral medication called AZD2389 for adults with steatotic liver disease (SLD), also known as fatty liver disease, and advanced fibrosis (scarring of the liver). AZD2389 works by targeting a specific protein called FAP that is involved in liver scarring. The main goals are to see how safe AZD2389 is, how well people tolerate it, and if it can improve liver scarring as measured by the Enhanced Liver Fibrosis (ELF) score after 24 weeks. Researchers will also track any side effects and changes in blood pressure. You may be able to join if you are 18 or older, have SLD with advanced fibrosis, and meet other health criteria. The study aims to enroll about 104 participants.

Study design
This is a blinded study, meaning neither you nor your doctors will know if you are receiving AZD2389 or a placebo (an inactive substance). Approximately 104 participants will be randomly assigned to one of two groups.
What's involved
The study will last about 32 weeks, including a 4-week screening period, up to 24 weeks of treatment, and a 4-week follow-up. You will have visits approximately every 4 weeks, with some visits every 2 weeks early in the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks after the 24-week treatment period.

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NCT07610837

Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~104 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:AZD2389Placebo

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
Measured over 24 weeks
+14 more outcomes measured

Conditions

Liver Fibrosis
Hepatic Cirrhosis

Explore related trials

Hepatic SteatosisLiver Fibrosis

Where it's being run

20 sites across 9 states
Texas7
Florida3
Arizona2
Missouri2
North Carolina2
Nevada1
Ohio1
Oklahoma1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 2424 weeks

    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

  • Reported quantity and severity of adverse events (AEs)Up to and including Day 197

    To assess the safety and tolerability of AZD2389 in participants with SLD and advanced fibrosis

  • Number of participants with observed changes in blood pressure against baseline mmHg valueUp to and including Day 197

    Assess blood pressure level (with systolic and diastolic pressure) in mmHg

  • Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG)Up to and including Day 197

    12-lead safety ECG (PR interval, QRS complex, ST interval, T wave)

  • Number of participants with abnormal laboratory results detected in urine samplesUp to and including Day 197

    Urinalysis - Paper chromatography

  • Number of participants with observed changes in heart rate (BPM) against baseline valueUp to and including Day 197

    Pulse rate measured in beats per minute (BPM)

  • Number of participants with observed changes in Sp02 oxygen values against baseline measurementUp to and including Day 197

    Sp02 oxygen saturations measured by percentage

  • Number of participants with observed changes in body temperature against baseline valueUp to and including Day 197

    Body temperature measured in degrees Celsius

  • Number of participants with observed changes in respiratory rate against baseline valueUp to and including Day 197

    Respiratory rate measured in respirations per minute

  • Number of participants with abnormal laboratory test results detected in blood samplesUp to and including Day 197

    Hematology - Platelets (x10\^9/L)

  • Number of participants with abnormal laboratory test results detected in blood samplesUp to and including Day 197

    Coagulation - INR

  • Number of participants with abnormal laboratory test results detected in blood samplesUp to and including Day 197

    Clinical Chemistry - ALT (U/L)

  • Number of participants with abnormal laboratory test results detected in blood samplesUp to and including Day 197

    Fibrinolysis - D-dimer (ng/mL fibrinogen-equivalent units)

  • Number of participants with abnormal laboratory test results detected in blood samplesUp to and including Day 197

    Clinical Chemistry - AST (U/L)

  • Number of participants with abnormal laboratory test results detected in blood samplesUp to and including Day 197

    Clinical Chemistry - ALP (U/L)