> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iib-study-to-evaluate-azd8965-in-participants-with-af2da470-c1bc-4a4a-89c4-e1216ff75eed > Record changed: 2026-10-13 # A Phase IIb Study to Evaluate AZD8965 in Participants With IPF. NCT07652658 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) Participants 359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) Start date 2026-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) Number of sites 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Acronym** ARGiNAUT Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Short title** A Phase IIb Study to Evaluate AZD8965 in Participants With IPF. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Official title** A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Dates **Completion date** 2028-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **First posted** 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Registry last updated** 2026-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Primary completion date** 2028-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Start date** 2026-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Size and sites **Participants** 359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Planned participants** 359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Number of sites** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Identifiers **Registry ID** NCT07652658 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **ClinicalTrials.gov ID** NCT07652658 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Outcomes ### 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 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07652658) ## Related records ### Drugs (3) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) - [Samidorphan](https://trialight.com/data/asset/samidorphan-28d3f2c3-edbf-4d9b-a8ba-b5d5187b5cf9.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Primary condition ### Targets (6) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [OPRD1](https://trialight.com/data/target/oprd1-5ce8b0d6-c823-51ce-a7b3-812976633078.md) - [OPRK1](https://trialight.com/data/target/oprk1-7b0a0fa0-a4b4-537b-bd00-d871256424e5.md) - [OPRM1](https://trialight.com/data/target/oprm1-04284660-78ba-5225-a86d-21f8a7325d8f.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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