AZD8965 compared with placebo in adults with idiopathic pulmonary fibrosis
Tests 3 doses of AZD8965 against placebo in adults with idiopathic pulmonary fibrosis.
Key facts
- Who runs it
- AstraZeneca
- Where
- Ashkelon, Jerusalem, Kfar Saba, Petah Tikva, and Rehovot, IsraelSee the 5 sitesAlso in 22 other countries, 170 sites
- Trial code
- Registry title
- A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 359 people, planned
- Started
- 11 Jun 2026
- Expected to end
- 18 Sept 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo for AZD8965
- AZD8965 low dose
- AZD8965 medium dose
- AZD8965 high dose
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF), with or without current antifibrotic treatment.
- Age
- 40 years or older
- Sex
- All sexes can join.
- Disease stage
- IPF diagnosis. FVC at least 45% predicted of normal. DLCO corrected for hemoglobin at least 25% predicted of normal.
- Earlier treatment
- People can join if they take approved antifibrotic treatment at a stable dose, or if they do not take standard treatment for IPF.
Main reasons for not taking part
- Lung disease other than IPF
- More emphysema than fibrotic change on chest scan (HRCT)
- Acute worsening (exacerbation) of IPF
- Lower respiratory tract infection needing treatment
- History of organ transplant or likely to receive a lung transplant
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- ILD other than IPF
- The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
- Acute exacerbation of IPF
Where in Israel
Also in 22 other countries, 170 sites
- AshkelonHospital not named in the registryTaking people
- JerusalemHospital not named in the registryTaking people
- Kfar SabaHospital not named in the registryTaking people
- Petah TikvaHospital not named in the registryTaking people
- RehovotHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Placebo for AZD8965Placebo, for comparison
- AZD8965 low doseTreatment being tested
- AZD8965 medium doseTreatment being tested
- AZD8965 high doseTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)
- Plain-language title
- AZD8965 compared with placebo in adults with idiopathic pulmonary fibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 October 2026