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
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.