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.

This is a Phase IIb, randomized, placebo-controlled, double-blind, parallel-group 24-week study to assess the efficacy, safety and tolerability of three doses of AZD8965 versus placebo administered to participants with IPF. The enrolled participants will include those on stable dose(s) of one or two approved antifibrotic therapies and those who are not taking any antifibrotic therapy. Approximately 360 participants will be randomized across approximately 200 sites globally.

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

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.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.