RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07652658

Registry updated: 2026-09-21

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Description

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.

Interventions

Placebo for AZD8965 (Other)
Placebo for AZD8965
AZD8965 low dose (Drug)
AZD8965 low dose
AZD8965 medium dose (Drug)
AZD8965 medium dose
AZD8965 high dose (Drug)
AZD8965 high dose

Eligibility criteria

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

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Locations

Research Site — Birmingham, Alabama, United States
Research Site — Phoenix, Arizona, United States
Research Site — Phoenix, Arizona, United States
Research Site — Loma Linda, California, United States
Research Site — Los Angeles, California, United States
Research Site — Newport Beach, California, United States
Research Site — Sacramento, California, United States
Research Site — Stanford, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Denver, Colorado, United States
Research Site — Ocala, Florida, United States
Research Site — Weston, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Boise, Idaho, United States
Research Site — Champaign, Illinois, United States
Research Site — Chicago, Illinois, United States
Research Site — Kansas City, Kansas, United States
Research Site — Lexington, Kentucky, United States
Research Site — Baltimore, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Detroit, Michigan, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Greensboro, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Oklahoma City, Oklahoma, United States
Research Site — Bethlehem, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Charleston, South Carolina, United States
Research Site — Dallas, Texas, United States
Research Site — El Paso, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Burlington, Vermont, United States
Research Site — Richmond, Virginia, United States
Research Site — Alberdi, Argentina
Research Site — Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Florida, Argentina
Research Site — Rosario, Argentina
Research Site — San Fernando, Argentina
Research Site — Camperdown, Australia
Research Site — Port Macquarie, Australia
Research Site — Wollongong, Australia
Research Site — Haskovo, Bulgaria
Research Site — Plovdiv, Bulgaria
Research Site — Rousse, Bulgaria
Research Site — Rousse, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Sherwood Park, Alberta, Canada
Research Site — Vancouver, British Columbia, Canada
Research Site — Ajax, Ontario, Canada
Research Site — Burlington, Ontario, Canada
Research Site — Kingston, Ontario, Canada
Research Site — North York, Ontario, Canada
Research Site — Saint-Charles-Borromée, Quebec, Canada
Research Site — Sherbrooke, Quebec, Canada
Research Site — Providencia, Chile
Research Site — Santiago, Chile
Research Site — Talca, Chile
Research Site — Viña del Mar, Chile
Research Site — Viña del Mar, Chile
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Guangzhou, China
Research Site — Lanzhou, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Shanghai, China
Research Site — Shenyang, China
Research Site — Wuhan, China
Research Site — Xuzhou, China
Research Site — Zhengzhou, China
Research Site — Aarhus, Denmark
Research Site — Copenhagen, Denmark
Research Site — Hellerup, Denmark
Research Site — Odense C, Denmark
Research Site — Angers, France
Research Site — Brest, France
Research Site — Bron, France
Research Site — Montpellier, France
Research Site — Nice, France
Research Site — Paris, France
Research Site — Rennes, France
Research Site — Tours, France
Research Site — Bonn, Germany
Research Site — Essen, Germany
Research Site — Freiburg im Breisgau, Germany
Research Site — Fulda, Germany
Research Site — Giessen, Germany
Research Site — Hamburg, Germany
Research Site — Hanover, Germany
Research Site — Heidelberg, Germany
Research Site — Hemer, Germany
Research Site — Konstanz, Germany
Research Site — Leipzig, Germany
Research Site — Lübeck, Germany
Research Site — Marburg, Germany
Research Site — Munich, Germany
Research Site — Stuttgart, Germany
Research Site — Witten, Germany
Research Site — Wuppertal-Barmen, Germany
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Heraklion, Greece
Research Site — Ioannina, Greece
Research Site — Pátrai, Greece
Research Site — Thessaloniki, Greece
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Törökbálint, Hungary
Research Site — Ashkelon, Israel
Research Site — Jerusalem, Israel
Research Site — Kfar Saba, Israel
Research Site — Petah Tikva, Israel
Research Site — Rehovot, Israel
Research Site — Foggia, Italy
Research Site — Forlì, Italy
Research Site — Modena, Italy
Research Site — Monza, Italy
Research Site — Pavia, Italy
Research Site — Rozzano, Italy
Research Site — Siena, Italy
Research Site — Torino, Italy
Research Site — Fukuoka, Japan
Research Site — Hachioji-shi, Japan
Research Site — Hamamatsu, Japan
Research Site — Hiroshima, Japan
Research Site — Kakogawa-shi, Japan
Research Site — Kumagaya-shi, Japan
Research Site — Kumamoto, Japan
Research Site — Matsusaka-shi, Japan
Research Site — Sakaishi, Japan
Research Site — Sendai, Japan
Research Site — Seto-shi, Japan
Research Site — Shimotsuke-shi, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Yokohama, Japan
Research Site — Yokohama, Japan
Research Site — Benito Juárez, Mexico
Research Site — Chihuahua City, Mexico
Research Site — Coyocan, Mexico
Research Site — León, Mexico
Research Site — Mérida, Mexico
Research Site — Monterrey, Mexico
Research Site — Monterrey, Mexico
Research Site — Oaxaca City, Mexico
Research Site — Pachuca, Mexico
Research Site — Amsterdam, Netherlands
Research Site — Heerlen, Netherlands
Research Site — Nieuwegein, Netherlands
Research Site — Bialystok, Poland
Research Site — Krakow, Poland
Research Site — Lodz, Poland
Research Site — Poznan, Poland
Research Site — Rzeszów, Poland
Research Site — Warsaw, Poland
Research Site — Cape Town, South Africa
Research Site — Durban, South Africa
Research Site — Parktown West, South Africa
Research Site — Somerset West, South Africa
Research Site — Seongnam-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — L'Hospitalet de Llobregat, Spain
Research Site — Madrid, Spain
Research Site — Málaga, Spain
Research Site — Valencia, Spain
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Yunlin, Taiwan
Research Site — Bristol, United Kingdom
Research Site — Cottingham, United Kingdom
Research Site — Edinburgh, United Kingdom
Research Site — Exeter, United Kingdom
Research Site — Liverpool, United Kingdom
Research Site — London, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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