Liver FibrosisPhase 2BRAVONCT07610837
Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
A Phase 2 study testing AZD2389 in people with Liver Fibrosis and Hepatic Cirrhosis, run by AstraZeneca at 22 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Hepatic Cirrhosis
- What is being tested?
- AZD2389
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 7 May 2026to 7 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
22 sites in 2 countries
United States21 sites, 21 recruiting
- Recruiting
Research Site
Austin, Texas, 78757
- Recruiting
Research Site
Chandler, Arizona, 85224
- Recruiting
Research Site
Clarksville, Tennessee, 37040
- Recruiting
Research Site
Denison, Texas, 75020
- Recruiting
Research Site
Fresno, California, 93720
- Recruiting
Research Site
Georgetown, Texas, 78626
- Recruiting
Research Site
Houston, Texas, 77004
- Recruiting
Research Site
Houston, Texas, 77079
- Recruiting
Research Site
Jupiter, Florida, 33458
- Recruiting
Research Site
Kansas City, Missouri, 64131
- Recruiting
Research Site
Las Vegas, Nevada, 89106
- Recruiting
Research Site
Miami, Florida, 33122
- Recruiting
Research Site
Morehead City, North Carolina, 28557
- Recruiting
Research Site
Port Orange, Florida, 32127
- Recruiting
Research Site
Raleigh, North Carolina, 27607
- Recruiting
Research Site
San Antonio, Texas, 78215
- Recruiting
Research Site
San Antonio, Texas, 78222
- Recruiting
Research Site
St Louis, Missouri, 63123
- Recruiting
Research Site
Tucson, Arizona, 85712
- Recruiting
Research Site
Westlake, Ohio, 44145
- Recruiting
Research Site
Yukon, Oklahoma, 73099
About this study
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)
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.
Read the detailed description
Study details include:
- The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks.
- The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks.
Disclosure Statement:
This is a parallel group treatment study that is blinded to the participants and investigators.
Number of Participants:
Approximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approximately 52 participants will be randomised to receive AZD2389 and approximately 52 participants will receive placebo.
Note: 'Screened' means a participant's, or their legally authorised representative's, agreement to participate in a clinical study following completion of the informed consent process.
Study Arms and Duration:
Arm A will include 52 participants with SLD and advanced fibrosis who will receive oral AZD2389 for 24 weeks. Arm B will include 52 participants with SLD and advanced fibrosis who will receive oral placebo for 24 weeks.
- Conditions
- Liver Fibrosis, Hepatic Cirrhosis
- Being tested
- AZD2389, Placebo
- Keywords
- Liver Fibrosis, Hepatic Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2389Drug
Also called Active IMP
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.
PlaceboOther
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Doses of AZD2389 to be administered orally. Receives: Drug: AZD2389 |
| Arm B | Placebo comparator | Doses of placebo to be administered orally. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
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
Measured: 24 weeks
Reported quantity and severity of adverse events (AEs)
To assess the safety and tolerability of AZD2389 in participants with SLD and advanced fibrosis
Measured: Up to and including Day 197
Number of participants with observed changes in blood pressure against baseline mmHg value
Assess blood pressure level (with systolic and diastolic pressure) in mmHg
Measured: Up to and including Day 197
Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG)
12-lead safety ECG (PR interval, QRS complex, ST interval, T wave)
Measured: Up to and including Day 197
Number of participants with abnormal laboratory results detected in urine samples
Urinalysis - Paper chromatography
Measured: Up to and including Day 197
Number of participants with observed changes in heart rate (BPM) against baseline value
Pulse rate measured in beats per minute (BPM)
Measured: Up to and including Day 197
Number of participants with observed changes in Sp02 oxygen values against baseline measurement
Sp02 oxygen saturations measured by percentage
Measured: Up to and including Day 197
Number of participants with observed changes in body temperature against baseline value
Body temperature measured in degrees Celsius
Measured: Up to and including Day 197
Number of participants with observed changes in respiratory rate against baseline value
Respiratory rate measured in respirations per minute
Measured: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Hematology - Platelets (x10^9/L)
Measured: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Coagulation - INR
Measured: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Clinical Chemistry - ALT (U/L)
Measured: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Fibrinolysis - D-dimer (ng/mL fibrinogen-equivalent units)
Measured: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Clinical Chemistry - AST (U/L)
Measured: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Clinical Chemistry - ALP (U/L)
Measured: Up to and including Day 197
Secondary outcomes (5)
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in ProC3
Measured: 24 weeks
Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
Measured: 24 weeks
Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in CAP
Measured: 24 weeks
Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in ProC3
Measured: 24 weeks
Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start7 May 2026
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase IIa, randomised, double-blind, placebo-controlled, multicentre study to assess the safety, tolerability and PD effects of AZD2389 in participants with SLD and advanced fibrosis. Randomisation will be stratified by, type 2 diabetes mellitus (T2DM), and alcohol use. The purpose of this study is to evaluate the safety, tolerability, and PD of AZD2389 in adult participants with SLD and advanced fibrosis. Study details include: * The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks. * The visit frequency will be approximately every 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610837
- Sponsor's protocol ID
- D7930C00008
- Acronym
- BRAVO
- Status last verified
- Nov 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)
- ClinicalTrials.gov ID
- NCT07610837
- Acronym / sponsor ID
- BRAVO / D7930C00008
- Conditions
- Liver Fibrosis, Hepatic Cirrhosis
- Keywords
- Liver Fibrosis, Hepatic Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study details include:
- The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks.
- The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks.
Disclosure Statement:
This is a parallel group treatment study that is blinded to the participants and investigators.
Number of Participants:
Approximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approximately 52 participants will be randomised to receive AZD2389 and approximately 52 participants will receive placebo.
Note: 'Screened' means a participant's, or their legally authorised representative's, agreement to participate in a clinical study following completion of the informed consent process.
Study Arms and Duration:
Arm A will include 52 participants with SLD and advanced fibrosis who will receive oral AZD2389 for 24 weeks. Arm B will include 52 participants with SLD and advanced fibrosis who will receive oral placebo for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a Phase IIa, randomised, double-blind, placebo-controlled, multicentre study to assess the safety, tolerability and PD effects of AZD2389 in participants with SLD and advanced fibrosis. Randomisation will be stratified by, type 2 diabetes mellitus (T2DM), and alcohol use. The purpose of this study is to evaluate the safety, tolerability, and PD of AZD2389 in adult participants with SLD and advanced fibrosis. Study details include: * The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks. * The visit frequency will be approximately every 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AZD2389Doses of AZD2389 to be administered orally. |
| Arm B | Placebo comparator | Other: PlaceboDoses of placebo to be administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD2389Also: Active IMPpotent, 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. | Drug | Arm A |
| PlaceboOral administration | Other | Arm B |
Primary outcome
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)
5 secondary outcomes
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Time frame: 24 weeks
Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24
Time frame: 24 weeks
Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24
Time frame: 24 weeks
Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Time frame: 24 weeks
Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2389 in people with Liver Fibrosis and Hepatic Cirrhosis, run by AstraZeneca at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24 (time frame: 24 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.