Liver FibrosisPhase 2BORANANCT06750276
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
A Phase 2 study testing AZD2389 in people with Liver Fibrosis and Hepatic Cirrhosis, run by AstraZeneca at 9 sites in 3 countries.
Trial summary
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis. The study will also examine how the drug acts on the body 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?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 6 Dec 2024to 28 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Key inclusions:
- Males/females aged ≥ 18 years
- Indications: Presumed MASH (cohort A) or other steatotic liver disease (cohort B) with fibrosis
- No significant change in weight over the last 6 months
- Barrier contraceptives use by males
- Capable of informed consent
- Judged to be suitable for study by investigator
Key exclusions:
- A condition that could put the participant at risk, influence the participant's ability to participate in the trial, interfere with evaluation of the study intervention or affect the interpretation of the results
- Other causes of liver disease which are not the principal inclusion criteria for each cohort
- Significant elevations in liver blood tests or platelets <140 x10^9/L
- Decompensated liver disease, hepatobiliary cancer or listing for liver transplantation
- Bleeding disorders or major bleeding risk
- HIV infection or hepatitis B infection
- Clinically significant cardiovascular (e.g. severe ischaemic heart disease, severe heart failure or cardiac dysrhythmia) or cerebrovascular disease within the past 3 months
- Stage 2 hypertension
- eGFR <60ml/min/1.73m2
- Clinically significant gastrointestinal disease which can affect the interpretation of pharmacokinetic, safety, and tolerability data
- Skin disorders or ongoing wound healing
- Psychiatric disorders which may negatively affect participation in the trial.
- Females of childbearing potential
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Research Site
Atlanta, Georgia, 30349
Research Site
Chandler, Arizona, 85224
Research Site
Houston, Texas, 77079
Research Site
Morehead City, North Carolina, 28557
Research Site
Rialto, California, 92377
Research Site
San Antonio, Texas, 78215
Research Site
San Antonio, Texas, 78229
About this study
Official title: A Phase 2a, Randomised, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Explore the Pharmacodynamic Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis. The study will also examine how the drug acts on the body
Read the detailed description
Study details include:
The study duration will be up to 63 days (9 weeks).
- 1 or 2 screening visits (up to 28 days before treatment)
- 28 days of treatment including 5 clinic visits
- Week 1: 24-hour in-clinic stay (Day 1)
- Week 2: Outpatient clinic visit (Day 7)
- Week 3: Outpatient clinic visit (Day 14)
- Week 4: Telephone visit (Day 21)
- Week 5: 24 to 48-hour in-clinic stay (Day 28)
- Week 6: Follow-up visit (Day 35) Disclosure Statement: The study consists of two cohorts, each with a parallel-group design and two arms, with participants blinded to treatment allocation.
Number of Participants:
The study will randomise approximately 36 participants in total. Cohort A: Approximately 75 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: Approximately 75 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
- Conditions
- Liver Fibrosis, Hepatic Cirrhosis
- Being tested
- AZD2389
- 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
Doses of AZD2389 or placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AZD2389 |
| 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. Receives: Drug: AZD2389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Notable Trends in Laboratory Assessments (Haematology, Coagulation, Clinical Chemistry, Fibrinolysis, and Urinalysis)
The number of participants with notable trends in laboratory assessments (haematology, coagulation, clinical chemistry, fibrinolysis, and urinalysis) is presented.
Notable trends were assessed based on evaluation of mean values over time, individual participant values, and clinically important abnormalities, including values outside predefined criteria.
Measured: From screening up to and including Day 35
Clinically Relevant Trends in Vital Signs (Blood Pressure, Pulse Rate, Oxygen Saturation, Body Temperature, and Respiration Rate), and 12-lead Electrocardiogram (ECG)
The number of participants with clinically relevant trends in vital signs (blood pressure, pulse rate, oxygen saturation, body temperature, and respiration rate), and12-lead ECGs is presented.
Clinically relevant trends were assessed based on trends or group changes over time, changes in individual participants over time, and individual clinically important abnormalities.
Measured: From Screening up to and including Day 35
Secondary outcomes (12)
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Cmax
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
Cmax= Maximum Concentration
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Tmax
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
tmax = Time to Maximum Concentration
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: t1/2 Lambda z
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
t1/2 lambda z= Apparent Terminal Half-life
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: AUClast, AUCinf, and AUCtau
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
AUClast= Area Under the Concentration-time Curve to the Last Measurable Concentration AUCinf = Area Under the Concentration-time Curve Extrapolated to Infinity AUCtau = Area Under the Concentration-time Curve Over a Dosing Interval AUCtau presented as AUC(0-24h) in the table.
In line with standard PK analysis methodologies, AUCinf was estimated only for Day 1. AUClast and AUCtau were estimated for both Day 1 and Day 28.
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Lambda z
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
lambda z = Terminal elimination rate constant
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Vz/F
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
Vz/F = Apparent Volume of Distribution
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: CL/F and CLR
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
CL/F = Apparent Clearance CLR = Renal Clearance
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: TCP AUC
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
TCP is calculated as the ratio of steady-state AUCtau (AUC0-24h) to first-dose AUCinf TCP = Temporal Change Parameter AUC = Area Under the Concentration-time Curve
Measured: Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Rac AUC and Rac Cmax
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
Rac AUC = AUC Accumulation Ratio; ratio of steady state AUCtau (AUC0-24h)/First Dose AUCtau (AUC0-24h) Rac Cmax = Cmax Accumulation Ratio; ratio of steady state Cmax/First Dose Cmax
Measured: Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Ae (0-24)
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
Ae (0-24) = Cumulative Amount of Drug Excreted Unchanged in Urine
Measured: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Fe (0-24)
The PK of AZD2389 were evaluated following oral dosing in Cohort A and Cohort B and presented in table.
Fe = Fraction of Dose Excreted Unchanged into Urine
Measured: Day 1 and Day 28
Inhibition of FAP Activity Calculated as Percentage Change in FAP Activity Against Baseline Compared to Placebo.
Effect of AZD2389 on plasma FAP activity following oral administration of AZD2389 in participants with chronic Liver Disease and hepatic fibrosis was evaluated and presented as percentage change from baseline in FAP activity.
Percentage change when comparing post-treatment visits to baseline for each group, calculated as (Geometric LS mean - 1) *100.
FAP=Fibroblast Activating Protein
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 Dec 2024
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- The total duration of study participation for each participant in Cohorts A and B will be approximately 63 days (9 weeks) and will include an up to 28-day screening period, a 28-day treatment period, and a follow-up visit seven days following completion of treatment. Assessments will be conducted as described in the SoA.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750276
- Sponsor's protocol ID
- D7930C00002
- Acronym
- BORANA
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2024
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomised, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Explore the Pharmacodynamic Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT06750276
- Acronym / sponsor ID
- BORANA / D7930C00002
- Conditions
- Liver Fibrosis, Hepatic Cirrhosis
- Keywords
- Liver Fibrosis, Hepatic Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Posted 6 Jul 2026
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 measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis. The study will also examine how the drug acts on the body
Detailed description
Study details include:
The study duration will be up to 63 days (9 weeks).
- 1 or 2 screening visits (up to 28 days before treatment)
- 28 days of treatment including 5 clinic visits
- Week 1: 24-hour in-clinic stay (Day 1)
- Week 2: Outpatient clinic visit (Day 7)
- Week 3: Outpatient clinic visit (Day 14)
- Week 4: Telephone visit (Day 21)
- Week 5: 24 to 48-hour in-clinic stay (Day 28)
- Week 6: Follow-up visit (Day 35) Disclosure Statement: The study consists of two cohorts, each with a parallel-group design and two arms, with participants blinded to treatment allocation.
Number of Participants:
The study will randomise approximately 36 participants in total. Cohort A: Approximately 75 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: Approximately 75 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The total duration of study participation for each participant in Cohorts A and B will be approximately 63 days (9 weeks) and will include an up to 28-day screening period, a 28-day treatment period, and a follow-up visit seven days following completion of treatment. Assessments will be conducted as described in the SoA.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Drug: AZD2389Participants 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 | Drug: AZD2389Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AZD2389Doses of AZD2389 or placebo will be administered orally. | Drug | Cohort A, Cohort B |
Primary outcome
Notable Trends in Laboratory Assessments (Haematology, Coagulation, Clinical Chemistry, Fibrinolysis, and Urinalysis)
Time frame: From screening up to and including Day 35
The number of participants with notable trends in laboratory assessments (haematology, coagulation, clinical chemistry, fibrinolysis, and urinalysis) is presented. Notable trends were assessed based on evaluation of mean values over time, individual participant values, and clinically important abnormalities, including values outside predefined criteria.
Clinically Relevant Trends in Vital Signs (Blood Pressure, Pulse Rate, Oxygen Saturation, Body Temperature, and Respiration Rate), and 12-lead Electrocardiogram (ECG)
Time frame: From Screening up to and including Day 35
The number of participants with clinically relevant trends in vital signs (blood pressure, pulse rate, oxygen saturation, body temperature, and respiration rate), and12-lead ECGs is presented. Clinically relevant trends were assessed based on trends or group changes over time, changes in individual participants over time, and individual clinically important abnormalities.
12 secondary outcomes
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Cmax
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Tmax
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: t1/2 Lambda z
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: AUClast, AUCinf, and AUCtau
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Lambda z
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Vz/F
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: CL/F and CLR
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: TCP AUC
Time frame: Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Rac AUC and Rac Cmax
Time frame: Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Ae (0-24)
Time frame: Day 1 and Day 28
Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Fe (0-24)
Time frame: Day 1 and Day 28
Inhibition of FAP Activity Calculated as Percentage Change in FAP Activity Against Baseline Compared to Placebo.
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- d7930c00002\_Redacted CSR synopsisLink provided by the sponsor.
- d7930c00002\_Redacted\_SAPLink provided by the sponsor.
- d7930c00002\_Redacted\_CSPLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 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 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico, United Kingdom. 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. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Notable Trends in Laboratory Assessments (Haematology, Coagulation, Clinical Chemistry, Fibrinolysis, and Urinalysis) (time frame: From screening up to and including Day 35). The study lists 2 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 6 Jul 2026.