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

NCT07652658 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: D6960C00005
• Study Type: interventional
• Target: 359
• Locations: 22 countries
• Sites: 190

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (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

  at Week 24

Secondary Outcomes (7)

• Relationship between dose and clinical efficacy of AZD8965 at Week 24

  Week 24

• Change from baseline in FVC at Week 24

  Week 24

• Change in rate of decline in FVC at Week 24

  Week 24

• Number of participants with adverse events (AEs)

  Up to 25 weeks

• Number of participants with serious adverse events (SAEs)

  Up to 25 weeks

Study Arms (4)

Placebo for AZD8965

PLACEBO COMPARATOR

Placebo for AZD8965

Other: Placebo for AZD8965

AZD8965 low dose

EXPERIMENTAL

AZD8965 low dose

Drug: AZD8965 low dose

AZD8965 medium dose

EXPERIMENTAL

AZD8965 medium dose

Drug: AZD8965 medium dose

AZD8965 high dose

EXPERIMENTAL

AZD8965 high dose

Drug: AZD8965 high dose

Interventions

Placebo for AZD8965 OTHER

Placebo for AZD8965

Placebo for AZD8965

AZD8965 low dose DRUG

AZD8965 low dose

AZD8965 low dose

AZD8965 medium dose DRUG

AZD8965 medium dose

AZD8965 medium dose

AZD8965 high dose DRUG

AZD8965 high dose

AZD8965 high dose

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (190)

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Birmingham, Alabama, 35205, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85032, United States

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Loma Linda, California, 92350, United States

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Los Angeles, California, 90033, United States

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Newport Beach, California, 92663, United States

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Sacramento, California, 95817, United States

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Stanford, California, 94305, United States

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Aurora, Colorado, 80045, United States

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Denver, Colorado, 80206, United States

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Ocala, Florida, 34470, United States

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Weston, Florida, 33331, United States

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Atlanta, Georgia, 30322, United States

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Boise, Idaho, 83712, United States

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Champaign, Illinois, 61820, United States

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Chicago, Illinois, 60611, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40536, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02114, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48202, United States

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New York, New York, 10017, United States

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New York, New York, 10029, United States

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Greensboro, North Carolina, 27403, United States

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Cincinnati, Ohio, 45267, United States

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Oklahoma City, Oklahoma, 73117, United States

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Bethlehem, Pennsylvania, 18015, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19140, United States

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Charleston, South Carolina, 29425, United States

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Dallas, Texas, 75254, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77030, United States

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Burlington, Vermont, 05401, United States

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Richmond, Virginia, 23298, United States

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Alberdi, X5033DCE, Argentina

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Buenos Aires, 1425, Argentina

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Ciudad de Buenos Aires, C1414AIF, Argentina

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Florida, B1602DQD, Argentina

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Rosario, 2000, Argentina

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San Fernando, B1646EBJ, Argentina

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Port Macquarie, 2444, Australia

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Wollongong, 2500, Australia

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Haskovo, 6300, Bulgaria

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Plovdiv, 4001, Bulgaria

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Rousse, 7000, Bulgaria

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Sofia, 1618, Bulgaria

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Sofia, 1680, Bulgaria

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Sofia, 1756, Bulgaria

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Sherwood Park, Alberta, T8H 2M7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Kingston, Ontario, K7M 4E7, Canada

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North York, Ontario, M2K 1E1, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Providencia, 7500504, Chile

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Santiago, 7750495, Chile

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Talca, 3481349, Chile

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Viña del Mar, 2531172, Chile

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Viña del Mar, 2540488, Chile

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Beijing, 100000, China

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Beijing, 100029, China

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Beijing, 100730, China

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Changchun, 130041, China

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Changsha, 430033, China

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Chengdu, 610041, China

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Chengdu, 610078, China

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Guangzhou, 510735, China

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Lanzhou, 730030, China

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Nanchang, 330000, China

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Nanjing, 2100008, China

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Shanghai, 200433, China

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Shenyang, 110015, China

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Wuhan, 430048, China

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Xuzhou, 221000, China

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Zhengzhou, 450000, China

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Aarhus, 8200, Denmark

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Copenhagen, 2100, Denmark

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Hellerup, 2900, Denmark

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Odense C, 5000, Denmark

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Angers, 49933, France

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Brest, 29609, France

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Bron, 69677, France

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Montpellier, 34295, France

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Nice, 6000, France

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Paris, 75877, France

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Rennes, 35033, France

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Tours, 37000, France

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Bonn, 53127, Germany

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Essen, 45239, Germany

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Freiburg im Breisgau, 79106, Germany

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Fulda, 36043, Germany

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Giessen, 35392, Germany

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Hamburg, 20251, Germany

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Hanover, 30459, Germany

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Heidelberg, 69126, Germany

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Hemer, 58675, Germany

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Konstanz, 78464, Germany

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Leipzig, 04103, Germany

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Lübeck, 23538, Germany

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Marburg, 35037, Germany

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Munich, 81377, Germany

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Stuttgart, 70376, Germany

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Witten, 58452, Germany

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Wuppertal-Barmen, 42283, Germany

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Athens, 11527, Greece

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Athens, 12462, Greece

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Heraklion, 71110, Greece

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Ioannina, 45500, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 57010, Greece

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Budapest, 1083, Hungary

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Budapest, 1121, Hungary

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Debrecen, 4032, Hungary

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Törökbálint, 2045, Hungary

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Ashkelon, 78278, Israel

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Jerusalem, 9103102, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 4941492, Israel

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Rehovot, 76100, Israel

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Foggia, 71100, Italy

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Forlì, 47121, Italy

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Modena, 41124, Italy

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Monza, 20900, Italy

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Pavia, 27100, Italy

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Rozzano, 20089, Italy

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Siena, 53100, Italy

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Torino, 10126, Italy

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Fukuoka, 810-8563, Japan

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Hachioji-shi, 193-0998, Japan

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Hamamatsu, 431-3192, Japan

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Hiroshima, 734-8530, Japan

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Kakogawa-shi, 675-8611, Japan

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Kumagaya-shi, 360-0197, Japan

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Kumamoto, 861-4193, Japan

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Matsusaka-shi, 515-8544, Japan

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Sakaishi, 591-8555, Japan

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Sendai, 980-8574, Japan

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Seto-shi, 489-8642, Japan

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Shimotsuke-shi, 329-0498, Japan

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Shinjuku-ku, 162-8655, Japan

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Yokohama, 236-0037, Japan

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Yokohama, 236-0051, Japan

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Benito Juárez, 03330, Mexico

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Chihuahua City, 31203, Mexico

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Coyocan, 04330, Mexico

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León, 37160, Mexico

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Mérida, 97130, Mexico

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Monterrey, 64460, Mexico

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Monterrey, 64465, Mexico

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Oaxaca City, 68000, Mexico

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Pachuca, 42070, Mexico

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Bialystok, 15-044, Poland

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Krakow, 31-202, Poland

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Lodz, 90-153, Poland

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Poznan, 60-569, Poland

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Rzeszów, 35-205, Poland

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Warsaw, 02-507, Poland

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Cape Town, 7700, South Africa

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Durban, 4001, South Africa

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Parktown West, 2193, South Africa

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Somerset West, 7130, South Africa

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Seongnam-si, 13620, South Korea

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Seoul, 02841, South Korea

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Seoul, 04401, South Korea

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Seoul, 06351, South Korea

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Seoul, 5505, South Korea

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Barcelona, 08036, Spain

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Barcelona, 8025, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28006, Spain

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Málaga, 29010, Spain

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Valencia, 46010, Spain

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 824, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11220, Taiwan

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Taipei, 11696, Taiwan

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Taoyuan, 333, Taiwan

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Yunlin, 640, Taiwan

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Bristol, BS105NB, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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Exeter, EX2 5DW, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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London, SW3 6NP, United Kingdom

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MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): September 18, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

DE (17); GR (6); ZA (4); AU (2); TW (8); ES (6); US (36); IT (8); BU (6); AR (6); IL (5); KR (5); DK (4); FR (8); HU (4); JP (15); PL (6); CA (8); CL (5); GB (6); CN (16); ME (9)