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NCT Number: NCT07652658

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Alberdi, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo for AZD8965

Other

Placebo for AZD8965

AZD8965 low dose

Drug

AZD8965 low dose

AZD8965 medium dose

Drug

AZD8965 medium dose

AZD8965 high dose

Drug

AZD8965 high dose

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Relationship between dose and clinical efficacy of AZD8965 at Week 24

    Time frame: Week 24

    Change from baseline in FVC (in mL)

  2. Change from baseline in FVC at Week 24

    Time frame: Week 24

    Change from baseline in % predicted FVC

  3. Change in rate of decline in FVC at Week 24

    Time frame: Week 24

    Change in rate of decline in FVC (in mL/week)

  4. Number of participants with adverse events (AEs)

    Time frame: Up to 25 weeks

    Number of participants with AEs

  5. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 25 weeks

    Number of participants with SAEs

  6. Number of participants with AEs leading to discontinuation

    Time frame: Up to 25 weeks

    Number of participants with AEs leading to discontinuation

  7. Summary statistics to evaluate the PK of AZD8965

    Time frame: From baseline to Week 24

    AZD8965 concentrations in plasma

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ARGiNAUT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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