NCT07610837 · AstraZeneca
Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
(BRAVO)
What this study is about
The purpose of this study is to evaluate the safety, tolerability, and how the drug affects the body effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
View original scientific description
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
Interventions
DRUG
AZD2389
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.
OTHER
Placebo
Oral administration
Primary outcome measures
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
Time frame: 24 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)
Time frame: 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 value
Time frame: Up 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)
Time frame: 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 samples
Time frame: Up to and including Day 197
Urinalysis - Paper chromatography
Number of participants with observed changes in heart rate (BPM) against baseline value
Time frame: Up 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 measurement
Time frame: Up to and including Day 197
Sp02 oxygen saturations measured by percentage
Number of participants with observed changes in body temperature against baseline value
Time frame: Up to and including Day 197
Body temperature measured in degrees Celsius
Number of participants with observed changes in respiratory rate against baseline value
Time frame: Up to and including Day 197
Respiratory rate measured in respirations per minute
Number of participants with abnormal laboratory test results detected in blood samples
Time frame: Up to and including Day 197
Hematology - Platelets (x10\^9/L)
Number of participants with abnormal laboratory test results detected in blood samples
Time frame: Up to and including Day 197
Coagulation - INR
Number of participants with abnormal laboratory test results detected in blood samples
Time frame: Up to and including Day 197
Clinical Chemistry - ALT (U/L)
Number of participants with abnormal laboratory test results detected in blood samples
Time frame: Up to and including Day 197
Fibrinolysis - D-dimer (ng/mL fibrinogen-equivalent units)
Number of participants with abnormal laboratory test results detected in blood samples
Time frame: Up to and including Day 197
Clinical Chemistry - AST (U/L)
Number of participants with abnormal laboratory test results detected in blood samples
Time frame: Up to and including Day 197
Clinical Chemistry - ALP (U/L)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chandler, Arizona
- Tucson, Arizona
- Jupiter, Florida
- Miami, Florida
- Port Orange, Florida
- Kansas City, Missouri
- St Louis, Missouri
- Las Vegas, Nevada
- Morehead City, North Carolina
- Raleigh, North Carolina
- Westlake, Ohio
- Yukon, Oklahoma
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations