NCT07652658 A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
| NCT ID | NCT07652658 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Idiopathic Pulmonary Fibrosis (IPF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 359 participants |
| Start Date | 2026-06-11 |
| Primary Completion | 2028-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 359 participants in total. It began in 2026-06-11 with a primary completion date of 2028-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 40 years 2. IPF diagnosis 3. Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care 4. FVC ≥ 45% predicted of normal 5. DLCO corrected for hemoglobin ≥ 25% predicted of normal Exclusion Criteria: 1. ILD other than IPF 2. The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan 3. Acute exacerbation of IPF 4. Lower respiratory tract infection requiring treatment 5. Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting 6. Heart failure 7. History of organ transplantation or is likely to receive lung transplantation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07652658 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Idiopathic Pulmonary Fibrosis (IPF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07652658 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07652658 currently recruiting?
Yes, NCT07652658 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07652658 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Phoenix, United States, Loma Linda, United States and 11 additional locations.
Who is sponsoring the NCT07652658 clinical trial?
NCT07652658 is sponsored by AstraZeneca. The trial plans to enroll 359 participants.