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

June 24, 2026 updated by: AstraZeneca

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

359

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Alberdi, Argentina, X5033DCE
        • Not yet recruiting
        • Research Site
      • Buenos Aires, Argentina, 1425
        • Not yet recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1414AIF
        • Not yet recruiting
        • Research Site
      • Florida, Argentina, B1602DQD
        • Not yet recruiting
        • Research Site
      • Rosario, Argentina, 2000
        • Withdrawn
        • Research Site
      • San Fernando, Argentina, B1646EBJ
        • Not yet recruiting
        • Research Site
      • Port Macquarie, Australia, 2444
        • Not yet recruiting
        • Research Site
      • Wollongong, Australia, 2500
        • Not yet recruiting
        • Research Site
      • Haskovo, Bulgaria, 6300
        • Not yet recruiting
        • Research Site
      • Plovdiv, Bulgaria, 4001
        • Not yet recruiting
        • Research Site
      • Rousse, Bulgaria, 7000
        • Not yet recruiting
        • Research Site
      • Sofia, Bulgaria, 1618
        • Not yet recruiting
        • Research Site
      • Sofia, Bulgaria, 1680
        • Not yet recruiting
        • Research Site
      • Sofia, Bulgaria, 1756
        • Not yet recruiting
        • Research Site
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 2M7
        • Not yet recruiting
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Not yet recruiting
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Recruiting
        • Research Site
      • Burlington, Ontario, Canada, L7N 3V2
        • Not yet recruiting
        • Research Site
      • Kingston, Ontario, Canada, K7M 4E7
        • Recruiting
        • Research Site
      • North York, Ontario, Canada, M2K 1E1
        • Not yet recruiting
        • Research Site
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Not yet recruiting
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Not yet recruiting
        • Research Site
      • Providencia, Chile, 7500504
        • Not yet recruiting
        • Research Site
      • Santiago, Chile, 7750495
        • Not yet recruiting
        • Research Site
      • Talca, Chile, 3481349
        • Not yet recruiting
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Not yet recruiting
        • Research Site
      • Viña del Mar, Chile, 2531172
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100730
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100029
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100000
        • Not yet recruiting
        • Research Site
      • Changchun, China, 130041
        • Not yet recruiting
        • Research Site
      • Changsha, China, 430033
        • Not yet recruiting
        • Research Site
      • Chengdu, China, 610041
        • Not yet recruiting
        • Research Site
      • Chengdu, China, 610078
        • Not yet recruiting
        • Research Site
      • Guangzhou, China, 510735
        • Not yet recruiting
        • Research Site
      • Lanzhou, China, 730030
        • Not yet recruiting
        • Research Site
      • Nanchang, China, 330000
        • Not yet recruiting
        • Research Site
      • Nanjing, China, 2100008
        • Not yet recruiting
        • Research Site
      • Shanghai, China, 200433
        • Not yet recruiting
        • Research Site
      • Shenyang, China, 110015
        • Withdrawn
        • Research Site
      • Wuhan, China, 430048
        • Not yet recruiting
        • Research Site
      • Xuzhou, China, 221000
        • Not yet recruiting
        • Research Site
      • Zhengzhou, China, 450000
        • Not yet recruiting
        • Research Site
      • Aarhus, Denmark, 8200
        • Not yet recruiting
        • Research Site
      • Copenhagen, Denmark, 2100
        • Not yet recruiting
        • Research Site
      • Hellerup, Denmark, 2900
        • Not yet recruiting
        • Research Site
      • Odense C, Denmark, 5000
        • Not yet recruiting
        • Research Site
      • Angers, France, 49933
        • Not yet recruiting
        • Research Site
      • Brest, France, 29609
        • Not yet recruiting
        • Research Site
      • Bron, France, 69677
        • Not yet recruiting
        • Research Site
      • Montpellier, France, 34295
        • Not yet recruiting
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      • Nice, France, 6000
        • Not yet recruiting
        • Research Site
      • Paris, France, 75877
        • Not yet recruiting
        • Research Site
      • Rennes, France, 35033
        • Not yet recruiting
        • Research Site
      • Tours, France, 37000
        • Not yet recruiting
        • Research Site
      • Bonn, Germany, 53127
        • Not yet recruiting
        • Research Site
      • Essen, Germany, 45239
        • Not yet recruiting
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Not yet recruiting
        • Research Site
      • Fulda, Germany, 36043
        • Not yet recruiting
        • Research Site
      • Giessen, Germany, 35392
        • Not yet recruiting
        • Research Site
      • Hamburg, Germany, 20251
        • Not yet recruiting
        • Research Site
      • Hanover, Germany, 30459
        • Not yet recruiting
        • Research Site
      • Heidelberg, Germany, 69126
        • Not yet recruiting
        • Research Site
      • Hemer, Germany, 58675
        • Not yet recruiting
        • Research Site
      • Konstanz, Germany, 78464
        • Withdrawn
        • Research Site
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Research Site
      • Lübeck, Germany, 23538
        • Not yet recruiting
        • Research Site
      • Marburg, Germany, 35037
        • Not yet recruiting
        • Research Site
      • Munich, Germany, 81377
        • Not yet recruiting
        • Research Site
      • Stuttgart, Germany, 70376
        • Not yet recruiting
        • Research Site
      • Witten, Germany, 58452
        • Not yet recruiting
        • Research Site
      • Wuppertal-Barmen, Germany, 42283
        • Not yet recruiting
        • Research Site
      • Athens, Greece, 11527
        • Not yet recruiting
        • Research Site
      • Athens, Greece, 12462
        • Not yet recruiting
        • Research Site
      • Heraklion, Greece, 71110
        • Not yet recruiting
        • Research Site
      • Ioannina, Greece, 45500
        • Not yet recruiting
        • Research Site
      • Pátrai, Greece, 26500
        • Not yet recruiting
        • Research Site
      • Thessaloniki, Greece, 57010
        • Not yet recruiting
        • Research Site
      • Budapest, Hungary, 1083
        • Not yet recruiting
        • Research Site
      • Budapest, Hungary, 1121
        • Not yet recruiting
        • Research Site
      • Debrecen, Hungary, 4032
        • Not yet recruiting
        • Research Site
      • Törökbálint, Hungary, 2045
        • Not yet recruiting
        • Research Site
      • Ashkelon, Israel, 78278
        • Not yet recruiting
        • Research Site
      • Jerusalem, Israel, 9103102
        • Not yet recruiting
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Not yet recruiting
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Not yet recruiting
        • Research Site
      • Rehovot, Israel, 76100
        • Not yet recruiting
        • Research Site
      • Foggia, Italy, 71100
        • Not yet recruiting
        • Research Site
      • Forlì, Italy, 47121
        • Not yet recruiting
        • Research Site
      • Modena, Italy, 41124
        • Not yet recruiting
        • Research Site
      • Monza, Italy, 20900
        • Not yet recruiting
        • Research Site
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Research Site
      • Siena, Italy, 53100
        • Not yet recruiting
        • Research Site
      • Torino, Italy, 10126
        • Not yet recruiting
        • Research Site
      • Fukuoka, Japan, 810-8563
        • Not yet recruiting
        • Research Site
      • Hachioji-shi, Japan, 193-0998
        • Not yet recruiting
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Not yet recruiting
        • Research Site
      • Hiroshima, Japan, 734-8530
        • Not yet recruiting
        • Research Site
      • Kakogawa-shi, Japan, 675-8611
        • Not yet recruiting
        • Research Site
      • Kumagaya-shi, Japan, 360-0197
        • Not yet recruiting
        • Research Site
      • Kumamoto, Japan, 861-4193
        • Not yet recruiting
        • Research Site
      • Matsusaka-shi, Japan, 515-8544
        • Not yet recruiting
        • Research Site
      • Sakaishi, Japan, 591-8555
        • Not yet recruiting
        • Research Site
      • Sendai, Japan, 980-8574
        • Not yet recruiting
        • Research Site
      • Seto-shi, Japan, 489-8642
        • Not yet recruiting
        • Research Site
      • Shimotsuke-shi, Japan, 329-0498
        • Not yet recruiting
        • Research Site
      • Shinjuku-ku, Japan, 162-8655
        • Not yet recruiting
        • Research Site
      • Yokohama, Japan, 236-0051
        • Not yet recruiting
        • Research Site
      • Yokohama, Japan, 236-0037
        • Not yet recruiting
        • Research Site
      • Benito Juárez, Mexico, 03330
        • Not yet recruiting
        • Research Site
      • Chihuahua City, Mexico, 31203
        • Not yet recruiting
        • Research Site
      • Coyocan, Mexico, 04330
        • Not yet recruiting
        • Research Site
      • León, Mexico, 37160
        • Not yet recruiting
        • Research Site
      • Monterrey, Mexico, 64460
        • Not yet recruiting
        • Research Site
      • Monterrey, Mexico, 64465
        • Not yet recruiting
        • Research Site
      • Mérida, Mexico, 97130
        • Not yet recruiting
        • Research Site
      • Oaxaca City, Mexico, 68000
        • Not yet recruiting
        • Research Site
      • Pachuca, Mexico, 42070
        • Not yet recruiting
        • Research Site
      • Bialystok, Poland, 15-044
        • Not yet recruiting
        • Research Site
      • Krakow, Poland, 31-202
        • Withdrawn
        • Research Site
      • Lodz, Poland, 90-153
        • Not yet recruiting
        • Research Site
      • Poznan, Poland, 60-569
        • Not yet recruiting
        • Research Site
      • Rzeszów, Poland, 35-205
        • Not yet recruiting
        • Research Site
      • Warsaw, Poland, 02-507
        • Not yet recruiting
        • Research Site
      • Cape Town, South Africa, 7700
        • Not yet recruiting
        • Research Site
      • Durban, South Africa, 4001
        • Not yet recruiting
        • Research Site
      • Parktown West, South Africa, 2193
        • Not yet recruiting
        • Research Site
      • Somerset West, South Africa, 7130
        • Not yet recruiting
        • Research Site
      • Seongnam-si, South Korea, 13620
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 5505
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 02841
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 04401
        • Not yet recruiting
        • Research Site
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Research Site
      • Barcelona, Spain, 8025
        • Not yet recruiting
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08907
        • Not yet recruiting
        • Research Site
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Research Site
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Research Site
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Not yet recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 824
        • Not yet recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • Research Site
      • Taipei, Taiwan, 11220
        • Not yet recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • Research Site
      • Taipei, Taiwan, 11696
        • Not yet recruiting
        • Research Site
      • Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Research Site
      • Yunlin, Taiwan, 640
        • Not yet recruiting
        • Research Site
      • Bristol, United Kingdom, BS105NB
        • Not yet recruiting
        • Research Site
      • Cottingham, United Kingdom, HU16 5JQ
        • Not yet recruiting
        • Research Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Not yet recruiting
        • Research Site
      • Exeter, United Kingdom, EX2 5DW
        • Not yet recruiting
        • Research Site
      • Liverpool, United Kingdom, L9 7AL
        • Not yet recruiting
        • Research Site
      • London, United Kingdom, SW3 6NP
        • Not yet recruiting
        • Research Site
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Not yet recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Research Site
      • Phoenix, Arizona, United States, 85032
        • Not yet recruiting
        • Research Site
    • California
      • Loma Linda, California, United States, 92350
        • Not yet recruiting
        • Research Site
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Research Site
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Research Site
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • Research Site
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Research Site
      • Denver, Colorado, United States, 80206
        • Not yet recruiting
        • Research Site
    • Florida
      • Ocala, Florida, United States, 34470
        • Withdrawn
        • Research Site
      • Weston, Florida, United States, 33331
        • Not yet recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Not yet recruiting
        • Research Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Not yet recruiting
        • Research Site
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Not yet recruiting
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Research Site
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Research Site
      • New York, New York, United States, 10017
        • Not yet recruiting
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Not yet recruiting
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Not yet recruiting
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Not yet recruiting
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Not yet recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Not yet recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75254
        • Not yet recruiting
        • Research Site
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Research Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Not yet recruiting
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo for AZD8965
Placebo for AZD8965
Experimental: AZD8965 low dose
AZD8965 low dose
Experimental: AZD8965 medium dose
AZD8965 medium dose
Experimental: AZD8965 high dose
AZD8965 high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between dose and clinical efficacy of AZD8965 at Week 24
Time Frame: Week 24
Change from baseline in FVC (in mL)
Week 24
Change from baseline in FVC at Week 24
Time Frame: Week 24
Change from baseline in % predicted FVC
Week 24
Change in rate of decline in FVC at Week 24
Time Frame: Week 24
Change in rate of decline in FVC (in mL/week)
Week 24
Number of participants with adverse events (AEs)
Time Frame: Up to 25 weeks
Number of participants with AEs
Up to 25 weeks
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 25 weeks
Number of participants with SAEs
Up to 25 weeks
Number of participants with AEs leading to discontinuation
Time Frame: Up to 25 weeks
Number of participants with AEs leading to discontinuation
Up to 25 weeks
Summary statistics to evaluate the PK of AZD8965
Time Frame: From baseline to Week 24
AZD8965 concentrations in plasma
From baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2026

Primary Completion (Estimated)

September 14, 2028

Study Completion (Estimated)

September 14, 2028

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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