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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis (IPF)

In brief

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.

Key facts

Study ID

NCT07652658

Run by

AstraZeneca

People needed

359

Starts

2026-06-11

Expected to finish

2028-09-14

Last updated by the study team

2026-06-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 40 years
• IPF diagnosis
• Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care
• FVC ≥ 45% predicted of normal
• DLCO corrected for hemoglobin ≥ 25% predicted of normal

You may not qualify if…

• ILD other than IPF
• The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
• Acute exacerbation of IPF
• Lower respiratory tract infection requiring treatment
• Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting
• Heart failure
• History of organ transplantation or is likely to receive lung transplantation

Where it is running

• Research Site — Newport Beach, California, United States (enrolling)
• Research Site — Kingston, Ontario, Canada (enrolling)
• Research Site — Ajax, Ontario, Canada (enrolling)
• Research Site — El Paso, Texas, United States (enrolling)
• Research Site — Weston, Florida, United States
• Research Site — Sacramento, California, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Denver, Colorado, United States
• Research Site — Los Angeles, California, United States
• Research Site — Ocala, Florida, United States
• Research Site — New York, New York, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Boise, Idaho, United States
• Research Site — Champaign, Illinois, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Detroit, Michigan, United States
• Research Site — New York, New York, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Stanford, California, United States

Full record on ClinicalTrials.gov

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