AzTrials
AzTrials

Idiopathic Pulmonary Fibrosis (IPF)Phase 2ARGiNAUTNCT07652658

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

A Phase 2 study testing AZD8965 low dose, AZD8965 medium dose and AZD8965 high dose in people with Idiopathic Pulmonary Fibrosis (IPF), run by AstraZeneca at 198 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis (IPF)
What is being tested?
AZD8965 low dose, AZD8965 medium dose and AZD8965 high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
359 participants
Where
198 sitesin 23 countries
Study dates
11 Jun 2026to 18 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

198 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

198 sites in 23 countries

United States36 sites, 35 recruiting
  • Research Site

    Ann Arbor, Michigan, 48109

    Not yet recruiting
  • Research Site

    Atlanta, Georgia, 30322

    Recruiting
  • Research Site

    Aurora, Colorado, 80045

    Not yet recruiting
  • Research Site

    Baltimore, Maryland, 21201

    Not yet recruiting
  • Research Site

    Birmingham, Alabama, 35205

    Not yet recruiting
  • Research Site

    Boise, Idaho, 83702

    Recruiting
  • Research Site

    Boston, Massachusetts, 02114

    Not yet recruiting
  • Research Site

    Burlington, Vermont, 05401

    Not yet recruiting
  • Research Site

    Champaign, Illinois, 61820

    Recruiting
  • Research Site

    Charleston, South Carolina, 29425

    Not yet recruiting
  • Research Site

    Chicago, Illinois, 60611

    Not yet recruiting
  • Research Site

    Cincinnati, Ohio, 45267

    Not yet recruiting
  • Research Site

    Dallas, Texas, 75254

    Not yet recruiting
  • Research Site

    Denver, Colorado, 80206

    Recruiting
  • Research Site

    Detroit, Michigan, 48202

    Not yet recruiting
  • Research Site

    El Paso, Texas, 79902

    Recruiting
  • Research Site

    Fountain Hill, Pennsylvania, 18015

    Recruiting
  • Research Site

    Greensboro, North Carolina, 27403

    Not yet recruiting
  • Research Site

    Houston, Texas, 77030

    Not yet recruiting
  • Research Site

    Kansas City, Kansas, 66160

    Not yet recruiting
  • Research Site

    Lexington, Kentucky, 40536

    Not yet recruiting
  • Research Site

    Loma Linda, California, 92350

    Not yet recruiting
  • Research Site

    Los Angeles, California, 90033

    Not yet recruiting
  • Research Site

    New York, New York, 10017

    Not yet recruiting
  • Research Site

    New York, New York, 10029

    Recruiting
  • Research Site

    Newport Beach, California, 92663

    Recruiting
  • Research Site

    Ocala, Florida, 34470

    Withdrawn
  • Research Site

    Oklahoma City, Oklahoma, 73104

    Not yet recruiting
  • Research Site

    Philadelphia, Pennsylvania, 19104

    Not yet recruiting
  • Research Site

    Philadelphia, Pennsylvania, 19140

    Recruiting
  • Research Site

    Phoenix, Arizona, 85006

    Not yet recruiting
  • Research Site

    Phoenix, Arizona, 85032

    Recruiting
  • Research Site

    Richmond, Virginia, 23298

    Not yet recruiting
  • Research Site

    Sacramento, California, 95817

    Not yet recruiting
  • Research Site

    Stanford, California, 94305

    Not yet recruiting
  • Research Site

    Weston, Florida, 33331

    Not yet recruiting

Other trials in United States

Germany18 sites, 15 recruiting
  • Research Site

    Bonn, 53127

    Recruiting
  • Research Site

    Coswig, 01640

    Not yet recruiting
  • Research Site

    Essen, 45239

    Recruiting
  • Research Site

    Freiburg im Breisgau, 79106

    Recruiting
  • Research Site

    Fulda, 36043

    Not yet recruiting
  • Research Site

    Giessen, 35392

    Recruiting
  • Research Site

    Hamburg, 20251

    Not yet recruiting
  • Research Site

    Hanover, 30459

    Recruiting
  • Research Site

    Heidelberg, 69126

    Withdrawn
  • Research Site

    Hemer, 58675

    Recruiting
  • Research Site

    Konstanz, 78464

    Withdrawn
  • Research Site

    Leipzig, 04103

    Not yet recruiting
  • Research Site

    Lübeck, 23538

    Not yet recruiting
  • Research Site

    Marburg, 35037

    Recruiting
  • Research Site

    Munich, 81377

    Recruiting
  • Research Site

    Stuttgart, 70376

    Recruiting
  • Research Site

    Witten, 58452

    Withdrawn
  • Research Site

    Wuppertal-Barmen, 42283

    Recruiting

Other trials in Germany

China16 sites, 15 recruiting
  • Research Site

    Beijing, 100000

    Recruiting
  • Research Site

    Beijing, 100029

    Recruiting
  • Research Site

    Beijing, 100730

    Not yet recruiting
  • Research Site

    Changchun, 130041

    Recruiting
  • Research Site

    Changsha, 430033

    Not yet recruiting
  • Research Site

    Chengdu, 610041

    Recruiting
  • Research Site

    Chengdu, 610078

    Recruiting
  • Research Site

    Guangzhou, 510220

    Recruiting
  • Research Site

    Lanzhou, 730030

    Not yet recruiting
  • Research Site

    Nanchang, 330000

    Not yet recruiting
  • Research Site

    Nanjing, 2100008

    Recruiting
  • Research Site

    Shanghai, 200433

    Recruiting
  • Research Site

    Shenyang, 110015

    Withdrawn
  • Research Site

    Wuhan, 430030

    Recruiting
  • Research Site

    Xuzhou, 221000

    Recruiting
  • Research Site

    Zhengzhou, 450000

    Not yet recruiting

Other trials in China

Japan15 sites, 15 recruiting
  • Research Site

    Fukuoka, 810-8563

    Recruiting
  • Research Site

    Hachioji-shi, 193-0998

    Recruiting
  • Research Site

    Hamamatsu, 431-3192

    Not yet recruiting
  • Research Site

    Hiroshima, 734-8530

    Recruiting
  • Research Site

    Kakogawa-shi, 675-8611

    Recruiting
  • Research Site

    Kumagaya-shi, 360-0197

    Recruiting
  • Research Site

    Kumamoto, 861-4193

    Not yet recruiting
  • Research Site

    Matsusaka-shi, 515-8544

    Recruiting
  • Research Site

    Sakaishi, 591-8555

    Not yet recruiting
  • Research Site

    Sendai, 980-8574

    Not yet recruiting
  • Research Site

    Seto-shi, 489-8642

    Not yet recruiting
  • Research Site

    Shimotsuke-shi, 329-0498

    Not yet recruiting
  • Research Site

    Shinjuku-ku, 162-8655

    Recruiting
  • Research Site

    Yokohama, 236-0037

    Recruiting
  • Research Site

    Yokohama, 236-0051

    Not yet recruiting

Other trials in Japan

Mexico9 sites, 9 recruiting
  • Research Site

    Benito Juárez, 03330

    Not yet recruiting
  • Research Site

    Chihuahua City, 31203

    Not yet recruiting
  • Research Site

    Coyocan, 04330

    Not yet recruiting
  • Research Site

    León, 37160

    Not yet recruiting
  • Research Site

    Mérida, 97130

    Not yet recruiting
  • Research Site

    Monterrey, 64460

    Not yet recruiting
  • Research Site

    Monterrey, 64465

    Not yet recruiting
  • Research Site

    Oaxaca City, 68000

    Not yet recruiting
  • Research Site

    Pachuca, 42070

    Not yet recruiting

Other trials in Mexico

Bulgaria8 sites, 6 recruiting
  • Research Site

    Haskovo, 6300

    Withdrawn
  • Research Site

    Plovdiv, 4001

    Not yet recruiting
  • Research Site

    Rousse, 7000

    Recruiting
  • Research Site

    Rousse, 7002

    Not yet recruiting
  • Research Site

    Sofia, 1000

    Not yet recruiting
  • Research Site

    Sofia, 1618

    Recruiting
  • Research Site

    Sofia, 1680

    Withdrawn
  • Research Site

    Sofia, 1756

    Not yet recruiting

Other trials in Bulgaria

Canada8 sites, 8 recruiting
  • Research Site

    Ajax, Ontario, L1S 2J5

    Recruiting
  • Research Site

    Burlington, Ontario, L7N 3V2

    Recruiting
  • Research Site

    Kingston, Ontario, K7M 4E7

    Recruiting
  • Research Site

    North York, Ontario, M2K 1E1

    Recruiting
  • Research Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

    Recruiting
  • Research Site

    Sherbrooke, Quebec, J1H 5N4

    Recruiting
  • Research Site

    Sherwood Park, Alberta, T8H 2M7

    Not yet recruiting
  • Research Site

    Vancouver, British Columbia, V5Z 1M9

    Not yet recruiting

Other trials in Canada

France8 sites, 8 recruiting
  • Research Site

    Angers, 49933

    Not yet recruiting
  • Research Site

    Brest, 29609

    Recruiting
  • Research Site

    Bron, 69677

    Recruiting
  • Research Site

    Montpellier, 34295

    Not yet recruiting
  • Research Site

    Nice, 6000

    Recruiting
  • Research Site

    Paris, 75877

    Not yet recruiting
  • Research Site

    Rennes, 35033

    Not yet recruiting
  • Research Site

    Tours, 37000

    Recruiting

Other trials in France

Italy8 sites, 8 recruiting
  • Research Site

    Foggia, 71100

    Recruiting
  • Research Site

    Forlì, 47121

    Not yet recruiting
  • Research Site

    Modena, 41124

    Not yet recruiting
  • Research Site

    Monza, 20900

    Not yet recruiting
  • Research Site

    Pavia, 27100

    Recruiting
  • Research Site

    Rozzano, 20089

    Recruiting
  • Research Site

    Siena, 53100

    Recruiting
  • Research Site

    Torino, 10126

    Not yet recruiting

Other trials in Italy

Taiwan8 sites, 8 recruiting
  • Research Site

    Kaohsiung City, 80756

    Recruiting
  • Research Site

    Kaohsiung City, 824

    Recruiting
  • Research Site

    Taichung, 40705

    Recruiting
  • Research Site

    Taipei, 10002

    Recruiting
  • Research Site

    Taipei, 11220

    Recruiting
  • Research Site

    Taipei, 11696

    Recruiting
  • Research Site

    Taoyuan, 333

    Recruiting
  • Research Site

    Yunlin, 640

    Recruiting

Other trials in Taiwan

Greece7 sites, 7 recruiting
  • Research Site

    Athens, 11527

    Not yet recruiting
  • Research Site

    Athens, 11527

    Recruiting
  • Research Site

    Athens, 12462

    Recruiting
  • Research Site

    Heraklion, 71110

    Recruiting
  • Research Site

    Ioannina, 45500

    Recruiting
  • Research Site

    Pátrai, 26504

    Not yet recruiting
  • Research Site

    Thessaloniki, 57010

    Recruiting

Other trials in Greece

Argentina6 sites, 5 recruiting
  • Research Site

    Alberdi, X5033DCE

    Not yet recruiting
  • Research Site

    Buenos Aires, 1425

    Not yet recruiting
  • Research Site

    Ciudad de Buenos Aires, C1414AIF

    Not yet recruiting
  • Research Site

    Florida, B1602DQD

    Not yet recruiting
  • Research Site

    Rosario, 2000

    Withdrawn
  • Research Site

    San Fernando, B1646EBJ

    Not yet recruiting

Other trials in Argentina

Poland6 sites, 4 recruiting
  • Research Site

    Bialystok, 15-044

    Recruiting
  • Research Site

    Krakow, 31-202

    Withdrawn
  • Research Site

    Lodz, 90-153

    Withdrawn
  • Research Site

    Poznan, 60-569

    Not yet recruiting
  • Research Site

    Rzeszów, 35-205

    Recruiting
  • Research Site

    Warsaw, 02-507

    Recruiting

Other trials in Poland

Spain6 sites, 6 recruiting
  • Research Site

    Barcelona, 08036

    Not yet recruiting
  • Research Site

    Barcelona, 8025

    Not yet recruiting
  • Research Site

    L'Hospitalet de Llobregat, 08907

    Not yet recruiting
  • Research Site

    Madrid, 28006

    Not yet recruiting
  • Research Site

    Málaga, 29010

    Recruiting
  • Research Site

    Valencia, 46010

    Recruiting

Other trials in Spain

United Kingdom6 sites, 6 recruiting
  • Research Site

    Bristol, BS105NB

    Recruiting
  • Research Site

    Cottingham, HU16 5JQ

    Recruiting
  • Research Site

    Edinburgh, EH16 4SA

    Recruiting
  • Research Site

    Exeter, EX2 5DW

    Recruiting
  • Research Site

    Liverpool, L9 7AL

    Recruiting
  • Research Site

    London, SW3 6NP

    Recruiting

Other trials in United Kingdom

Chile5 sites, 5 recruiting
  • Research Site

    Providencia, 7500504

    Recruiting
  • Research Site

    Santiago, 7750495

    Recruiting
  • Research Site

    Talca, 3481349

    Recruiting
  • Research Site

    Viña del Mar, 2531172

    Recruiting
  • Research Site

    Viña del Mar, 2540488

    Recruiting

Other trials in Chile

Israel5 sites, 5 recruiting
  • Research Site

    Ashkelon, 78278

    Recruiting
  • Research Site

    Jerusalem, 9103102

    Recruiting
  • Research Site

    Kfar Saba, 4428164

    Recruiting
  • Research Site

    Petah Tikva, 4941492

    Recruiting
  • Research Site

    Rehovot, 76100

    Recruiting

Other trials in Israel

South Korea5 sites, 5 recruiting
  • Research Site

    Seongnam-si, 13620

    Recruiting
  • Research Site

    Seoul, 02841

    Recruiting
  • Research Site

    Seoul, 04401

    Recruiting
  • Research Site

    Seoul, 06351

    Recruiting
  • Research Site

    Seoul, 5505

    Recruiting

Other trials in South Korea

Denmark4 sites, 4 recruiting
  • Research Site

    Aarhus, 8200

    Recruiting
  • Research Site

    Copenhagen, 2100

    Not yet recruiting
  • Research Site

    Hellerup, 2900

    Recruiting
  • Research Site

    Odense C, 5000

    Recruiting

Other trials in Denmark

Hungary4 sites, 4 recruiting
  • Research Site

    Budapest, 1083

    Not yet recruiting
  • Research Site

    Budapest, 1121

    Not yet recruiting
  • Research Site

    Debrecen, 4032

    Not yet recruiting
  • Research Site

    Törökbálint, 2045

    Recruiting

Other trials in Hungary

South Africa4 sites, 3 recruiting
  • Research Site

    Cape Town, 7700

    Recruiting
  • Research Site

    Durban, 4001

    Recruiting
  • Research Site

    Parktown West, 2193

    Not yet recruiting
  • Research Site

    Somerset West, 7130

    Withdrawn

Other trials in South Africa

Australia3 sites, 3 recruiting
  • Research Site

    Camperdown, 2050

    Not yet recruiting
  • Research Site

    Port Macquarie, 2444

    Recruiting
  • Research Site

    Wollongong, 2500

    Recruiting

Other trials in Australia

Netherlands3 sites, 3 recruiting
  • Research Site

    Amsterdam, 1081 HV

    Not yet recruiting
  • Research Site

    Heerlen, 6419 PC

    Recruiting
  • Research Site

    Nieuwegein, 3435 CM

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Placebo for AZD8965, AZD8965 low dose, AZD8965 medium dose, AZD8965 high dose
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo for AZD8965Other

    Placebo for AZD8965

  • AZD8965 low doseDrug

    AZD8965 low dose

  • AZD8965 medium doseDrug

    AZD8965 medium dose

  • AZD8965 high doseDrug

    AZD8965 high dose

Study groups in NCT07652658
Study groupRoleWhat they receive
Placebo for AZD8965Placebo comparatorPlacebo for AZD8965
Receives: Other: Placebo for AZD8965
AZD8965 low doseExperimentalAZD8965 low dose
Receives: Drug: AZD8965 low dose
AZD8965 medium doseExperimentalAZD8965 medium dose
Receives: Drug: AZD8965 medium dose
AZD8965 high doseExperimentalAZD8965 high dose
Receives: Drug: AZD8965 high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at Week 24

Secondary outcomes (7)
  1. Relationship between dose and clinical efficacy of AZD8965 at Week 24

    Change from baseline in FVC (in mL)

    Measured: Week 24

  2. Change from baseline in FVC at Week 24

    Change from baseline in % predicted FVC

    Measured: Week 24

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

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

    Measured: Week 24

  4. Number of participants with adverse events (AEs)

    Number of participants with AEs

    Measured: Up to 25 weeks

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

    Number of participants with SAEs

    Measured: Up to 25 weeks

  6. Number of participants with AEs leading to discontinuation

    Number of participants with AEs leading to discontinuation

    Measured: Up to 25 weeks

  7. Summary statistics to evaluate the PK of AZD8965

    AZD8965 concentrations in plasma

    Measured: From baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start11 Jun 2026
  3. Primary completion18 Sep 2028 (estimated)
  4. Study completion18 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
359 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07652658
Sponsor's protocol ID
D6960C00005
Acronym
ARGiNAUT
Status last verified
Oct 2026
First submitted
5 May 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD8965 low dose, AZD8965 medium dose and AZD8965 high dose in people with Idiopathic Pulmonary Fibrosis (IPF), run by AstraZeneca at 198 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, Germany, China, Japan, Mexico and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in