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A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)

Who can join

Ages 40 and older · All sexes

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

About the study

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.

What is being tested

• Placebo for AZD8965 (other)
• AZD8965 low dose (drug)
• AZD8965 medium dose (drug)
• AZD8965 high dose (drug)

Sponsor: AstraZeneca · Participants: 359 · Started: Jun 11, 2026

Contact the study team

• AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479

Official record on ClinicalTrials.gov — NCT07652658

Locations in the U.S.

Conditions

• Idiopathic Pulmonary Fibrosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.