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

NCT07652658
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
359
clinicaltrials.gov
Lead sponsor
AstraZeneca
clinicaltrials.gov
Start date
2026-06-11
clinicaltrials.gov
Number of sites
190
clinicaltrials.gov

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.
clinicaltrials.gov
Acronym
ARGiNAUT
clinicaltrials.gov
Short title
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
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)
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-09-14
clinicaltrials.gov
First posted
2026-06-17
clinicaltrials.gov
Registry last updated
2026-06-25
clinicaltrials.gov
Primary completion date
2028-09-14
clinicaltrials.gov
Start date
2026-06-11
clinicaltrials.gov

Participants
359
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
359
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
190
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
AstraZeneca
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07652658
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07652658
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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

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

    Timeframe: Week 24

    Change from baseline in FVC (in mL)

  2. Change from baseline in FVC at Week 24

    Timeframe: Week 24

    Change from baseline in % predicted FVC

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

    Timeframe: Week 24

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

  4. Number of participants with adverse events (AEs)

    Timeframe: Up to 25 weeks

    Number of participants with AEs

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

    Timeframe: Up to 25 weeks

    Number of participants with SAEs

  6. Number of participants with AEs leading to discontinuation

    Timeframe: Up to 25 weeks

    Number of participants with AEs leading to discontinuation

  7. Summary statistics to evaluate the PK of AZD8965

    Timeframe: From baseline to Week 24

    AZD8965 concentrations in plasma

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  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

  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
Sources for eligibility
clinicaltrials.gov

  • Research SiteBirmingham, United StatesNot yet recruiting
  • Research SitePhoenix, United StatesNot yet recruiting
  • Research SitePhoenix, United StatesNot yet recruiting
  • Research SiteLoma Linda, United StatesNot yet recruiting
  • Research SiteLos Angeles, United StatesNot yet recruiting
  • Research SiteNewport Beach, United StatesRecruiting
  • Research SiteSacramento, United StatesNot yet recruiting
  • Research SiteStanford, United StatesNot yet recruiting
  • Research SiteAurora, United StatesNot yet recruiting
  • Research SiteDenver, United StatesNot yet recruiting
  • Research SiteOcala, United StatesWithdrawn
  • Research SiteWeston, United StatesNot yet recruiting
  • Research SiteAtlanta, United StatesNot yet recruiting
  • Research SiteBoise, United StatesNot yet recruiting
  • Research SiteChampaign, United StatesNot yet recruiting
  • Research SiteChicago, United StatesNot yet recruiting
  • Research SiteKansas City, United StatesNot yet recruiting
  • Research SiteLexington, United StatesNot yet recruiting
  • Research SiteBaltimore, United StatesNot yet recruiting
  • Research SiteBoston, United StatesNot yet recruiting
  • Research SiteAnn Arbor, United StatesNot yet recruiting
  • Research SiteDetroit, United StatesNot yet recruiting
  • Research SiteNew York, United StatesNot yet recruiting
  • Research SiteNew York, United StatesNot yet recruiting
  • Research SiteGreensboro, United StatesNot yet recruiting

And 165 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (6)