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

October 28, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
359

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • 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
  • Australia
      • Camperdown, Australia, 2050
        • Not yet recruiting
        • Research Site
      • Port Macquarie, Australia, 2444
        • Recruiting
        • Research Site
      • Wollongong, Australia, 2500
        • Recruiting
        • Research Site
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Withdrawn
        • Research Site
      • Plovdiv, Bulgaria, 4001
        • Not yet recruiting
        • Research Site
      • Rousse, Bulgaria, 7000
        • Recruiting
        • Research Site
      • Rousse, Bulgaria, 7002
        • Not yet recruiting
        • Research Site
      • Sofia, Bulgaria, 1680
        • Withdrawn
        • Research Site
      • Sofia, Bulgaria, 1618
        • Recruiting
        • Research Site
      • Sofia, Bulgaria, 1000
        • Not yet recruiting
        • Research Site
      • Sofia, Bulgaria, 1756
        • Not yet recruiting
        • Research Site
  • Canada
    • 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
        • Recruiting
        • Research Site
      • Kingston, Ontario, Canada, K7M 4E7
        • Recruiting
        • Research Site
      • North York, Ontario, Canada, M2K 1E1
        • Recruiting
        • Research Site
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Recruiting
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Research Site
  • Chile
      • Providencia, Chile, 7500504
        • Recruiting
        • Research Site
      • Santiago, Chile, 7750495
        • Recruiting
        • Research Site
      • Talca, Chile, 3481349
        • Recruiting
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Recruiting
        • Research Site
      • Viña del Mar, Chile, 2531172
        • Recruiting
        • Research Site
  • China
      • Beijing, China, 100029
        • Recruiting
        • Research Site
      • Beijing, China, 100730
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100000
        • Recruiting
        • Research Site
      • Changchun, China, 130041
        • Recruiting
        • Research Site
      • Changsha, China, 430033
        • Not yet recruiting
        • Research Site
      • Chengdu, China, 610041
        • Recruiting
        • Research Site
      • Chengdu, China, 610078
        • Recruiting
        • Research Site
      • Guangzhou, China, 510220
        • Recruiting
        • Research Site
      • Lanzhou, China, 730030
        • Not yet recruiting
        • Research Site
      • Nanchang, China, 330000
        • Not yet recruiting
        • Research Site
      • Nanjing, China, 2100008
        • Recruiting
        • Research Site
      • Shanghai, China, 200433
        • Recruiting
        • Research Site
      • Shenyang, China, 110015
        • Withdrawn
        • Research Site
      • Wuhan, China, 430030
        • Recruiting
        • Research Site
      • Xuzhou, China, 221000
        • Recruiting
        • Research Site
      • Zhengzhou, China, 450000
        • Not yet recruiting
        • Research Site
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Research Site
      • Copenhagen, Denmark, 2100
        • Not yet recruiting
        • Research Site
      • Hellerup, Denmark, 2900
        • Recruiting
        • Research Site
      • Odense C, Denmark, 5000
        • Recruiting
        • Research Site
  • France
      • Angers, France, 49933
        • Not yet recruiting
        • Research Site
      • Brest, France, 29609
        • Recruiting
        • Research Site
      • Bron, France, 69677
        • Recruiting
        • Research Site
      • Montpellier, France, 34295
        • Not yet recruiting
        • Research Site
      • Nice, France, 6000
        • Recruiting
        • Research Site
      • Paris, France, 75877
        • Not yet recruiting
        • Research Site
      • Rennes, France, 35033
        • Not yet recruiting
        • Research Site
      • Tours, France, 37000
        • Recruiting
        • Research Site
  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • Research Site
      • Coswig, Germany, 01640
        • Not yet recruiting
        • Research Site
      • Essen, Germany, 45239
        • Recruiting
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Research Site
      • Fulda, Germany, 36043
        • Not yet recruiting
        • Research Site
      • Giessen, Germany, 35392
        • Recruiting
        • Research Site
      • Hamburg, Germany, 20251
        • Not yet recruiting
        • Research Site
      • Hanover, Germany, 30459
        • Recruiting
        • Research Site
      • Heidelberg, Germany, 69126
        • Withdrawn
        • Research Site
      • Hemer, Germany, 58675
        • 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
        • Recruiting
        • Research Site
      • Munich, Germany, 81377
        • Recruiting
        • Research Site
      • Stuttgart, Germany, 70376
        • Recruiting
        • Research Site
      • Witten, Germany, 58452
        • Withdrawn
        • Research Site
      • Wuppertal-Barmen, Germany, 42283
        • Recruiting
        • Research Site
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Research Site
      • Athens, Greece, 11527
        • Not yet recruiting
        • Research Site
      • Athens, Greece, 11527
        • Recruiting
        • Research Site
      • Heraklion, Greece, 71110
        • Recruiting
        • Research Site
      • Ioannina, Greece, 45500
        • Recruiting
        • Research Site
      • Pátrai, Greece, 26504
        • Not yet recruiting
        • Research Site
      • Thessaloniki, Greece, 57010
        • Recruiting
        • Research Site
  • Hungary
      • 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
        • Recruiting
        • Research Site
  • Israel
      • Ashkelon, Israel, 78278
        • Recruiting
        • Research Site
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Research Site
      • Rehovot, Israel, 76100
        • Recruiting
        • Research Site
  • Italy
      • Foggia, Italy, 71100
        • 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
        • Recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Recruiting
        • Research Site
      • Siena, Italy, 53100
        • Recruiting
        • Research Site
      • Torino, Italy, 10126
        • Not yet recruiting
        • Research Site
  • Japan
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • Research Site
      • Hachioji-shi, Japan, 193-0998
        • Recruiting
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Not yet recruiting
        • Research Site
      • Hiroshima, Japan, 734-8530
        • Recruiting
        • Research Site
      • Kakogawa-shi, Japan, 675-8611
        • Recruiting
        • Research Site
      • Kumagaya-shi, Japan, 360-0197
        • Recruiting
        • Research Site
      • Kumamoto, Japan, 861-4193
        • Not yet recruiting
        • Research Site
      • Matsusaka-shi, Japan, 515-8544
        • 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
        • Recruiting
        • Research Site
      • Yokohama, Japan, 236-0037
        • Recruiting
        • Research Site
      • Yokohama, Japan, 236-0051
        • Not yet recruiting
        • Research Site
  • Mexico
      • 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
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Not yet recruiting
        • Research Site
      • Heerlen, Netherlands, 6419 PC
        • Recruiting
        • Research Site
      • Nieuwegein, Netherlands, 3435 CM
        • Recruiting
        • Research Site
  • Poland
      • Bialystok, Poland, 15-044
        • Recruiting
        • Research Site
      • Krakow, Poland, 31-202
        • Withdrawn
        • Research Site
      • Lodz, Poland, 90-153
        • Withdrawn
        • Research Site
      • Poznan, Poland, 60-569
        • Not yet recruiting
        • Research Site
      • Rzeszów, Poland, 35-205
        • Recruiting
        • Research Site
      • Warsaw, Poland, 02-507
        • Recruiting
        • Research Site
  • South Africa
      • Cape Town, South Africa, 7700
        • Recruiting
        • Research Site
      • Durban, South Africa, 4001
        • Recruiting
        • Research Site
      • Parktown West, South Africa, 2193
        • Not yet recruiting
        • Research Site
      • Somerset West, South Africa, 7130
        • Withdrawn
        • Research Site
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Research Site
      • Seoul, South Korea, 5505
        • Recruiting
        • Research Site
      • Seoul, South Korea, 02841
        • Recruiting
        • Research Site
      • Seoul, South Korea, 04401
        • Recruiting
        • Research Site
  • Spain
      • 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
        • Recruiting
        • Research Site
      • Valencia, Spain, 46010
        • Recruiting
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 824
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 11220
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 11696
        • Recruiting
        • Research Site
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Research Site
      • Yunlin, Taiwan, 640
        • Recruiting
        • Research Site
  • United Kingdom
      • Bristol, United Kingdom, BS105NB
        • Recruiting
        • Research Site
      • Cottingham, United Kingdom, HU16 5JQ
        • Recruiting
        • Research Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Research Site
      • Exeter, United Kingdom, EX2 5DW
        • Recruiting
        • Research Site
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • Research Site
      • London, United Kingdom, SW3 6NP
        • Recruiting
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Not yet recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Research Site
      • Phoenix, Arizona, United States, 85006
        • 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
        • 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
        • Recruiting
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • Research Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • 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
        • 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, 73104
        • Not yet recruiting
        • Research Site
    • Pennsylvania
      • Fountain Hill, Pennsylvania, United States, 18015
        • Recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19140
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo for AZD8965

Placebo for AZD8965
Other: Placebo for AZD8965

Placebo for AZD8965
Experimental: AZD8965 low dose

AZD8965 low dose
Drug: AZD8965 low dose

AZD8965 low dose
Experimental: AZD8965 medium dose

AZD8965 medium dose
Drug: AZD8965 medium dose

AZD8965 medium dose
Experimental: AZD8965 high dose

AZD8965 high dose
Drug: AZD8965 high dose

AZD8965 high dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

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Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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