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

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

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Other: Placebo for AZD8965; Drug: AZD8965 low dose; Drug: AZD8965 medium dose; Drug: AZD8965 high dose

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

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo for AZD8965	Other: Placebo for AZD8965; Placebo for AZD8965
Experimental: AZD8965 low dose	Drug: AZD8965 low dose; AZD8965 low dose
Experimental: AZD8965 medium dose	Drug: AZD8965 medium dose; AZD8965 medium dose
Experimental: AZD8965 high dose	Drug: 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	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	Change from baseline in FVC (in mL)	Week 24
Change from baseline in FVC at Week 24	Change from baseline in % predicted FVC	Week 24
Change in rate of decline in FVC at Week 24	Change in rate of decline in FVC (in mL/week)	Week 24
Number of participants with adverse events (AEs)	Number of participants with AEs	Up to 25 weeks
Number of participants with serious adverse events (SAEs)	Number of participants with SAEs	Up to 25 weeks
Number of participants with AEs leading to discontinuation	Number of participants with AEs leading to discontinuation	Up to 25 weeks
Summary statistics to evaluate the PK of AZD8965	AZD8965 concentrations in plasma	From baseline to Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): September 18, 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 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: D6960C00005

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