- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07652658
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Alberdi, Argentina, X5033DCE
- Not yet recruiting
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Buenos Aires, Argentina, 1425
- Not yet recruiting
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Ciudad de Buenos Aires, Argentina, C1414AIF
- Not yet recruiting
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Florida, Argentina, B1602DQD
- Not yet recruiting
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Rosario, Argentina, 2000
- Withdrawn
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San Fernando, Argentina, B1646EBJ
- Not yet recruiting
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Port Macquarie, Australia, 2444
- Not yet recruiting
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Wollongong, Australia, 2500
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Haskovo, Bulgaria, 6300
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Plovdiv, Bulgaria, 4001
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Rousse, Bulgaria, 7000
- Not yet recruiting
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Sofia, Bulgaria, 1618
- Not yet recruiting
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Sofia, Bulgaria, 1680
- Not yet recruiting
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Sofia, Bulgaria, 1756
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Alberta
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Sherwood Park, Alberta, Canada, T8H 2M7
- Not yet recruiting
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Not yet recruiting
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
- Recruiting
- Research Site
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Burlington, Ontario, Canada, L7N 3V2
- Not yet recruiting
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Kingston, Ontario, Canada, K7M 4E7
- Recruiting
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North York, Ontario, Canada, M2K 1E1
- Not yet recruiting
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Quebec
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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
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Sherbrooke, Quebec, Canada, J1H 5N4
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Providencia, Chile, 7500504
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Santiago, Chile, 7750495
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Talca, Chile, 3481349
- Not yet recruiting
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Viña del Mar, Chile, 2540488
- Not yet recruiting
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Viña del Mar, Chile, 2531172
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Beijing, China, 100730
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Beijing, China, 100029
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Beijing, China, 100000
- Not yet recruiting
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Changchun, China, 130041
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Changsha, China, 430033
- Not yet recruiting
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Chengdu, China, 610041
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Chengdu, China, 610078
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Guangzhou, China, 510735
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Lanzhou, China, 730030
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Nanchang, China, 330000
- Not yet recruiting
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Nanjing, China, 2100008
- Not yet recruiting
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Shanghai, China, 200433
- Not yet recruiting
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Shenyang, China, 110015
- Withdrawn
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Wuhan, China, 430048
- Not yet recruiting
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Xuzhou, China, 221000
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Zhengzhou, China, 450000
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Aarhus, Denmark, 8200
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Copenhagen, Denmark, 2100
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Hellerup, Denmark, 2900
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Odense C, Denmark, 5000
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Angers, France, 49933
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Brest, France, 29609
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Bron, France, 69677
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Montpellier, France, 34295
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Nice, France, 6000
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Paris, France, 75877
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Rennes, France, 35033
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Tours, France, 37000
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Bonn, Germany, 53127
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Essen, Germany, 45239
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Freiburg im Breisgau, Germany, 79106
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Fulda, Germany, 36043
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Giessen, Germany, 35392
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Hamburg, Germany, 20251
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Hanover, Germany, 30459
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Heidelberg, Germany, 69126
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Hemer, Germany, 58675
- Not yet recruiting
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Konstanz, Germany, 78464
- Withdrawn
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Leipzig, Germany, 04103
- Not yet recruiting
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Lübeck, Germany, 23538
- Not yet recruiting
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Marburg, Germany, 35037
- Not yet recruiting
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Munich, Germany, 81377
- Not yet recruiting
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Stuttgart, Germany, 70376
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Witten, Germany, 58452
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Wuppertal-Barmen, Germany, 42283
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Athens, Greece, 11527
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Athens, Greece, 12462
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Heraklion, Greece, 71110
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Ioannina, Greece, 45500
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Pátrai, Greece, 26500
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Thessaloniki, Greece, 57010
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Budapest, Hungary, 1083
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Budapest, Hungary, 1121
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Debrecen, Hungary, 4032
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Törökbálint, Hungary, 2045
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Ashkelon, Israel, 78278
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Jerusalem, Israel, 9103102
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Kfar Saba, Israel, 4428164
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Petah Tikva, Israel, 4941492
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Rehovot, Israel, 76100
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Foggia, Italy, 71100
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Forlì, Italy, 47121
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Modena, Italy, 41124
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Monza, Italy, 20900
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Pavia, Italy, 27100
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Rozzano, Italy, 20089
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Siena, Italy, 53100
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Torino, Italy, 10126
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Fukuoka, Japan, 810-8563
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Hachioji-shi, Japan, 193-0998
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Hamamatsu, Japan, 431-3192
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Hiroshima, Japan, 734-8530
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Kakogawa-shi, Japan, 675-8611
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Kumagaya-shi, Japan, 360-0197
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Kumamoto, Japan, 861-4193
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Matsusaka-shi, Japan, 515-8544
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Sakaishi, Japan, 591-8555
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Sendai, Japan, 980-8574
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Seto-shi, Japan, 489-8642
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Shimotsuke-shi, Japan, 329-0498
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Shinjuku-ku, Japan, 162-8655
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Yokohama, Japan, 236-0051
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Yokohama, Japan, 236-0037
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Benito Juárez, Mexico, 03330
- Not yet recruiting
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Chihuahua City, Mexico, 31203
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Coyocan, Mexico, 04330
- Not yet recruiting
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León, Mexico, 37160
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Monterrey, Mexico, 64460
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Monterrey, Mexico, 64465
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Mérida, Mexico, 97130
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Oaxaca City, Mexico, 68000
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Pachuca, Mexico, 42070
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Bialystok, Poland, 15-044
- Not yet recruiting
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Krakow, Poland, 31-202
- Withdrawn
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Lodz, Poland, 90-153
- Not yet recruiting
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Poznan, Poland, 60-569
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Rzeszów, Poland, 35-205
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Warsaw, Poland, 02-507
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Cape Town, South Africa, 7700
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Durban, South Africa, 4001
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Parktown West, South Africa, 2193
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Somerset West, South Africa, 7130
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Seongnam-si, South Korea, 13620
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Seoul, South Korea, 5505
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Seoul, South Korea, 06351
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Seoul, South Korea, 02841
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Seoul, South Korea, 04401
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Barcelona, Spain, 08036
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Barcelona, Spain, 8025
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L'Hospitalet de Llobregat, Spain, 08907
- Not yet recruiting
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Madrid, Spain, 28006
- Not yet recruiting
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Málaga, Spain, 29010
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Valencia, Spain, 46010
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Kaohsiung City, Taiwan, 80756
- Not yet recruiting
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Kaohsiung City, Taiwan, 824
- Not yet recruiting
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Taichung, Taiwan, 40705
- Not yet recruiting
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Taipei, Taiwan, 11220
- Not yet recruiting
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Taipei, Taiwan, 10002
- Not yet recruiting
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Taipei, Taiwan, 11696
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Taoyuan, Taiwan, 333
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Yunlin, Taiwan, 640
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Bristol, United Kingdom, BS105NB
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Cottingham, United Kingdom, HU16 5JQ
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Edinburgh, United Kingdom, EH16 4SA
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Exeter, United Kingdom, EX2 5DW
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Liverpool, United Kingdom, L9 7AL
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London, United Kingdom, SW3 6NP
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Alabama
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Birmingham, Alabama, United States, 35205
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Arizona
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Phoenix, Arizona, United States, 85006
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Phoenix, Arizona, United States, 85032
- Not yet recruiting
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California
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Loma Linda, California, United States, 92350
- Not yet recruiting
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Los Angeles, California, United States, 90033
- Not yet recruiting
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Newport Beach, California, United States, 92663
- Recruiting
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Sacramento, California, United States, 95817
- Not yet recruiting
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Stanford, California, United States, 94305
- Not yet recruiting
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
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Denver, Colorado, United States, 80206
- Not yet recruiting
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Florida
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Ocala, Florida, United States, 34470
- Withdrawn
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Weston, Florida, United States, 33331
- Not yet recruiting
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Georgia
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Atlanta, Georgia, United States, 30322
- Not yet recruiting
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Idaho
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Boise, Idaho, United States, 83712
- Not yet recruiting
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Illinois
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Champaign, Illinois, United States, 61820
- Not yet recruiting
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Chicago, Illinois, United States, 60611
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Kansas
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Kansas City, Kansas, United States, 66160
- Not yet recruiting
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Kentucky
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Lexington, Kentucky, United States, 40536
- Not yet recruiting
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Maryland
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Baltimore, Maryland, United States, 21201
- Not yet recruiting
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Not yet recruiting
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Not yet recruiting
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Detroit, Michigan, United States, 48202
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New York
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New York, New York, United States, 10029
- Not yet recruiting
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New York, New York, United States, 10017
- Not yet recruiting
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North Carolina
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Greensboro, North Carolina, United States, 27403
- Not yet recruiting
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Ohio
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Cincinnati, Ohio, United States, 45267
- Not yet recruiting
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73117
- Not yet recruiting
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- Not yet recruiting
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Philadelphia, Pennsylvania, United States, 19140
- Not yet recruiting
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Philadelphia, Pennsylvania, United States, 19104
- Not yet recruiting
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South Carolina
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Charleston, South Carolina, United States, 29425
- Not yet recruiting
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Texas
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Dallas, Texas, United States, 75254
- Not yet recruiting
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El Paso, Texas, United States, 79902
- Recruiting
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Houston, Texas, United States, 77030
- Not yet recruiting
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Vermont
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Burlington, Vermont, United States, 05401
- Not yet recruiting
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Virginia
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Richmond, Virginia, United States, 23298
- Not yet recruiting
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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:
- 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
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 |
|---|---|
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Placebo Comparator: Placebo for AZD8965
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Placebo for AZD8965
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Experimental: AZD8965 low dose
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AZD8965 low dose
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Experimental: AZD8965 medium dose
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AZD8965 medium dose
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Experimental: AZD8965 high dose
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AZD8965 high dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
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at Week 24
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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)
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Week 24
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Change from baseline in FVC at Week 24
Time Frame: Week 24
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Change from baseline in % predicted FVC
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Week 24
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Change in rate of decline in FVC at Week 24
Time Frame: Week 24
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Change in rate of decline in FVC (in mL/week)
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Week 24
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Number of participants with adverse events (AEs)
Time Frame: Up to 25 weeks
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Number of participants with AEs
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Up to 25 weeks
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Number of participants with serious adverse events (SAEs)
Time Frame: Up to 25 weeks
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Number of participants with SAEs
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Up to 25 weeks
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Number of participants with AEs leading to discontinuation
Time Frame: Up to 25 weeks
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Number of participants with AEs leading to discontinuation
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Up to 25 weeks
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Summary statistics to evaluate the PK of AZD8965
Time Frame: From baseline to Week 24
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AZD8965 concentrations in plasma
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From baseline to Week 24
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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
Additional Relevant MeSH Terms
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
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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