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

NCT07652658 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Phase 2

Started

2026-06-11

Last updated

2026-06-25

Condition(s) studied

Idiopathic Pulmonary Fibrosis (IPF)

Investigational drug(s) / intervention(s)

Placebo for AZD8965AZD8965 low doseAZD8965 medium doseAZD8965 high dose

Placebo for AZD8965: Placebo for AZD8965

AZD8965 low dose: AZD8965 low dose

AZD8965 medium dose: AZD8965 medium dose

AZD8965 high dose: AZD8965 high dose

Study 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

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24 — at Week 24
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24

Trial sites (190)

Facility	City	Region	Status
Research Site	Birmingham	Alabama	Not Yet Recruiting
Research Site	Phoenix	Arizona	Not Yet Recruiting
Research Site	Phoenix	Arizona	Not Yet Recruiting
Research Site	Loma Linda	California	Not Yet Recruiting
Research Site	Los Angeles	California	Not Yet Recruiting
Research Site	Newport Beach	California	Recruiting
Research Site	Sacramento	California	Not Yet Recruiting
Research Site	Stanford	California	Not Yet Recruiting
Research Site	Aurora	Colorado	Not Yet Recruiting
Research Site	Denver	Colorado	Not Yet Recruiting
Research Site	Ocala	Florida	Withdrawn
Research Site	Weston	Florida	Not Yet Recruiting
Research Site	Atlanta	Georgia	Not Yet Recruiting
Research Site	Boise	Idaho	Not Yet Recruiting
Research Site	Champaign	Illinois	Not Yet Recruiting
Research Site	Chicago	Illinois	Not Yet Recruiting
Research Site	Kansas City	Kansas	Not Yet Recruiting
Research Site	Lexington	Kentucky	Not Yet Recruiting
Research Site	Baltimore	Maryland	Not Yet Recruiting
Research Site	Boston	Massachusetts	Not Yet Recruiting
Research Site	Ann Arbor	Michigan	Not Yet Recruiting
Research Site	Detroit	Michigan	Not Yet Recruiting
Research Site	New York	New York	Not Yet Recruiting
Research Site	New York	New York	Not Yet Recruiting
Research Site	Greensboro	North Carolina	Not Yet Recruiting
Research Site	Cincinnati	Ohio	Not Yet Recruiting
Research Site	Oklahoma City	Oklahoma	Not Yet Recruiting
Research Site	Bethlehem	Pennsylvania	Not Yet Recruiting
Research Site	Philadelphia	Pennsylvania	Not Yet Recruiting
Research Site	Philadelphia	Pennsylvania	Not Yet Recruiting
Research Site	Charleston	South Carolina	Not Yet Recruiting
Research Site	Dallas	Texas	Not Yet Recruiting
Research Site	El Paso	Texas	Recruiting
Research Site	Houston	Texas	Not Yet Recruiting
Research Site	Burlington	Vermont	Not Yet Recruiting
Research Site	Richmond	Virginia	Not Yet Recruiting
Research Site	Alberdi	Argentina	Not Yet Recruiting
Research Site	Buenos Aires	Argentina	Not Yet Recruiting
Research Site	Ciudad de Buenos Aires	Argentina	Not Yet Recruiting
Research Site	Florida	Argentina	Not Yet Recruiting

+ 150 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis Recruiting

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL) Recruiting

A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. Active, not recruiting

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652658 on ClinicalTrials.gov ↗ ← All trials in the UK