Liver FibrosisPhase 1PECHORANCT07069725
The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis.
A Phase 1 study testing AZD2389 and PET scan and radioligand in people with Liver Fibrosis and Hepatic Cirrhosis, run by AstraZeneca at 1 site in Sweden.
Trial summary
This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Fibrosis, Hepatic Cirrhosis
- What is being tested?
- AZD2389 and PET scan and radioligand
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 26 May 2025to 2 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (of non-childbearing potential) participant aged ≥ 20 years and willing and able to give written informed consent for participation in the trial.
- History confirming compensated liver cirrhosis.
- Females must have a negative pregnancy test.
- Barrier contraceptives use by males.
Who cannot join
- A condition that would interfere with evaluation of the trial intervention, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the trial.
- Any clinically significant illness, medical or major surgical procedure or trauma prior randomization.
- Hepatitis B , hepatitis C and/or HIV infection.
- Significant elevations in liver blood test, MELD score >12 and platelets <100 x109/L g).
- eGFR) < 60 ml/min/1.73m2.
- History of decompensated liver cirrhosis.
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- Any participants with an aetiology of liver cirrhosis where the Investigator considers that PET signal uptake may be impacted.
- History of bleeding disorders and major bleeding risk.
- History of severe dermatological disorders or wound healing.
- Positive screening result for drugs of abuse or alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Positron Emission Tomography Trial to Assess Changes in Liver Uptake of [68Ga]Ga-FAPI-46 Following Oral Administration of Single Doses of AZD2389 to Patients With Advanced Liver Fibrosis (PECHORA).
This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis.
Read the detailed description
This is a phase 1, open-label, PET trial in male and female patients with advanced liver fibrosis. The trial will consist of up to 3 sequential panels: Part A (Pilot panel), Part B (Main panel - 3 dose levels of AZD2389, 2 participants per dose level.), and Part C (optional panel). The design of the trial is adaptive and adjustments in time points and/or number of assessments and samples can be made during the course of the trial.
- Conditions
- Liver Fibrosis, Hepatic Cirrhosis
- Being tested
- AZD2389, PET scan and radioligand
- 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 will be administrated orally
PET scan and radioligandDiagnostic test
Also called The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46.
PET scan and radioligand
| Study group | Role | What they receive |
|---|---|---|
| Part A | Other | In Part A, eligible participants (screening Visit 1) will return to the trial site for pre-assessments, confirmation of eligibility criteria, blood sampling for FAP concentration analysis (at the trial site), and the first PET examination (screening Visit 2). The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. Depending on the results of the initial PET examination, participants of Part A may be invited to continue the trial in Part B. In such a case they will participate in a total of 3 PET examinations, not exceeding predefined radiation exposure limits. If they do not participate further, they will complete the trial with a follow-up visit (Visit 3, telephone call) 7 days (±2 days) after the PET examination. Receives: Diagnostic Test: PET scan and radioligand |
| Part B1 | Experimental | In Part B1, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. Receives: Drug: AZD2389; Diagnostic Test: PET scan and radioligand |
| Part B2 | Experimental | In Part B2, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. Receives: Drug: AZD2389; Diagnostic Test: PET scan and radioligand |
| Part B3 | Experimental | In Part B3, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. Receives: Drug: AZD2389; Diagnostic Test: PET scan and radioligand |
| Part C | Experimental | In Part C (optional), participants attend the trial site during Visit 1 (screening, Day-35 to Day-14) to undergo an eligibility check. At Visit 2, the first PET examination with radioligand will be performed at least 5 days before IMP administration. At Visit 3 (Day 1), participants receive a single dose AZD2389, then undergo a second PET examination using the radioligand on Day 2, along with blood sampling for PK analysis and FAP activity. At Visit 4 (Day 8 ±2 days), participants will be admitted to the trial site for a second single dose, then undergo a third PET examination using the radioligand on Day 9, along with blood sampling. At Visit 5 (7 days ±2 days after the PET examination on Visit 4) and Visit 6 (30 days [+7 days]) after the drug administration on Visit 4), follow-up visits at the trial site take place for safety monitoring and follow-up of any AEs. Receives: Drug: AZD2389; Diagnostic Test: PET scan and radioligand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupancy, %: percent change from baseline in uptake of FAP PET radioligand [68Ga]Ga-FAPI-46 in the liver after a single dose of AZD2389.
To examine target FAP occupancy in the liver by AZD2389 as measured with [68Ga]Ga-FAPI-46 PET.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
Secondary outcomes (7)
Plasma concentrations of AZD2389.
To evaluate plasma PK of AZD2389 after single doses.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
AZD2389 PK parameters calculated by: the plasma concentration vs. time curve (AUC) from 0 to infinity (AUCinf) and maximum observed concentration (Cmax)
Blood sampling and analysis to evaluate PK plasma of AZD2389 after single doses.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
% FAP inhibition compared to baseline in plasma.
To evaluate the plasma target engagement of AZD2389 by assessment of plasma FAP inhibition following single oral dosing.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
% aTRV (for radioligand uptake).
To quantify test-retest reproducibility of radioligand [68Ga]Ga-FAPI-46 uptake in the liver.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
ICC (for radioligand uptake).
To quantify test-retest reproducibility of radioligand [68Ga]Ga-FAPI-46 uptake in the liver.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
Maximum possible target occupancy (Occmax).
A theoretical relationship between average concentration of AZD2389 in plasma during the PET examination and radioligand binding will be assumed to calculate maximum target occupancy, if possible, by curve fitting.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
The IC50 confidence interval
A theoretical relationship between average concentration of AZD2389 in plasma during the PET examination and radioligand binding will be assumed to calculate the confidence interval associated with the IC50.
Measured: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start26 May 2025
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069725
- Sponsor's protocol ID
- D7930C00003
- Acronym
- PECHORA
- Status last verified
- Jul 2026
- First submitted
- 9 May 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Positron Emission Tomography Trial to Assess Changes in Liver Uptake of [68Ga]Ga-FAPI-46 Following Oral Administration of Single Doses of AZD2389 to Patients With Advanced Liver Fibrosis (PECHORA).
- ClinicalTrials.gov ID
- NCT07069725
- Acronym / sponsor ID
- PECHORA / D7930C00003
- Conditions
- Liver Fibrosis, Hepatic Cirrhosis
- Keywords
- Liver Fibrosis, Hepatic Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Karolinska Institutet
- Study start
- 26 May 2025 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 17 Jul 2025 (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.
This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis.
Detailed description
This is a phase 1, open-label, PET trial in male and female patients with advanced liver fibrosis. The trial will consist of up to 3 sequential panels: Part A (Pilot panel), Part B (Main panel - 3 dose levels of AZD2389, 2 participants per dose level.), and Part C (optional panel). The design of the trial is adaptive and adjustments in time points and/or number of assessments and samples can be made during the course of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.
| Arm | Type | Receives |
|---|---|---|
| Part A | Other | Diagnostic Test: PET scan and radioligandIn Part A, eligible participants (screening Visit 1) will return to the trial site for pre-assessments, confirmation of eligibility criteria, blood sampling for FAP concentration analysis (at the trial site), and the first PET examination (screening Visit 2). The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46. Depending on the results of the initial PET examination, participants of Part A may be invited to continue the trial in Part B. In such a case they will participate in a total of 3 PET examinations, not exceeding predefined radiation exposure limits. If they do not participate further, they will complete the trial with a follow-up visit (Visit 3, telephone call) 7 days (±2 days) after the PET examination. |
| Part B1 | Experimental | Drug: AZD2389, Diagnostic Test: PET scan and radioligandIn Part B1, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. |
| Part B2 | Experimental | Drug: AZD2389, Diagnostic Test: PET scan and radioligandIn Part B2, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. |
| Part B3 | Experimental | Drug: AZD2389, Diagnostic Test: PET scan and radioligandIn Part B3, eligible participants who completed the first PET scan at the screening visit and/or Part A will return to the trial site for blood sampling for FAP concentration analysis and the second PET examination on Day 1 (Visit 3) using the radioligand [68Ga]Ga-FAPI-46. At Visit 4, on Day 7 (±2 days), participants will receive a single oral dose of AZD2389. After AZD2389 administration, the third PET examination will be performed at the PET Centre followed by blood sampling for PK analysis and FAP activity, after which the participants will return to the trial site for further follow-up and safety monitoring. The participants will then be discharged from the trial site. Two follow up visits will occur after administration of AZD2389. Visit 5 (7 days [±2 days]) and Visit 6 (30 days[+7 days]) will monitor for safety and follow-up of AEs. |
| Part C | Experimental | Drug: AZD2389, Diagnostic Test: PET scan and radioligandIn Part C (optional), participants attend the trial site during Visit 1 (screening, Day-35 to Day-14) to undergo an eligibility check. At Visit 2, the first PET examination with radioligand will be performed at least 5 days before IMP administration. At Visit 3 (Day 1), participants receive a single dose AZD2389, then undergo a second PET examination using the radioligand on Day 2, along with blood sampling for PK analysis and FAP activity. At Visit 4 (Day 8 ±2 days), participants will be admitted to the trial site for a second single dose, then undergo a third PET examination using the radioligand on Day 9, along with blood sampling. At Visit 5 (7 days ±2 days after the PET examination on Visit 4) and Visit 6 (30 days [+7 days]) after the drug administration on Visit 4), follow-up visits at the trial site take place for safety monitoring and follow-up of any AEs. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (of non-childbearing potential) participant aged ≥ 20 years and willing and able to give written informed consent for participation in the trial.
- History confirming compensated liver cirrhosis.
- Females must have a negative pregnancy test.
- Barrier contraceptives use by males.
Key exclusion criteria (10 listed)
- A condition that would interfere with evaluation of the trial intervention, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the trial.
- Any clinically significant illness, medical or major surgical procedure or trauma prior randomization.
- Hepatitis B , hepatitis C and/or HIV infection.
- Significant elevations in liver blood test, MELD score >12 and platelets <100 x109/L g).
- eGFR) < 60 ml/min/1.73m2.
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 will be administrated orally | Drug | Part B1, Part B2, Part B3, Part C |
| PET scan and radioligandAlso: The participants will perform the PET examination at the PET Centre using the radioligand [68Ga]Ga-FAPI-46.PET scan and radioligand | Diagnostic test | Part A, Part B1, Part B2, Part B3, Part C |
Primary outcome
Occupancy, %: percent change from baseline in uptake of FAP PET radioligand [68Ga]Ga-FAPI-46 in the liver after a single dose of AZD2389.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
To examine target FAP occupancy in the liver by AZD2389 as measured with [68Ga]Ga-FAPI-46 PET.
7 secondary outcomes
Plasma concentrations of AZD2389.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
AZD2389 PK parameters calculated by: the plasma concentration vs. time curve (AUC) from 0 to infinity (AUCinf) and maximum observed concentration (Cmax)
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
% FAP inhibition compared to baseline in plasma.
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
% aTRV (for radioligand uptake).
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
ICC (for radioligand uptake).
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
Maximum possible target occupancy (Occmax).
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
The IC50 confidence interval
Time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2389 and PET scan and radioligand in people with Liver Fibrosis and Hepatic Cirrhosis, run by AstraZeneca at 1 site in Sweden.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 27 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 1 site in Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occupancy, %: percent change from baseline in uptake of FAP PET radioligand [68Ga]Ga-FAPI-46 in the liver after a single dose of AZD2389. (time frame: PART B: Day 7(+/-2 days); PART C: Day 2 and Day 8 (+/-2 days)). 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 27 Jul 2026.