Recruiting
Phase 2

AZD8965

Sponsor:

AstraZeneca

Code:

NCT07652658

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Placebo for AZD8965

AZD8965 low dose

AZD8965 medium dose

AZD8965 high dose

Study Details

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)

Study ID

NCT07652658

Start date

Jun 11, 2026

Status verified date

Sep, 2026

Completion date

Sep 14, 2028

Anticipated

Primary completion date

Sep 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

359 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo for AZD8965

Placebo for AZD8965

experimental: AZD8965 low dose

AZD8965 low dose

experimental: AZD8965 medium dose

AZD8965 medium dose

experimental: AZD8965 high dose

AZD8965 high dose

Interventions

Placebo for AZD8965

Placebo for AZD8965

AZD8965 low dose

AZD8965 low dose

AZD8965 medium dose

AZD8965 medium dose

AZD8965 high dose

AZD8965 high dose

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 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85032

Research Site

Recruiting

Newport Beach, California, United States, 92663

Research Site

Recruiting

Champaign, Illinois, United States, 61820

Research Site

Recruiting

El Paso, Texas, United States, 79902

Research Site

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Research Site

Recruiting

Burlington, Ontario, Canada, L7N 3V2

Research Site

Recruiting

Kingston, Ontario, Canada, K7M 4E7

Research Site

Recruiting

North York, Ontario, Canada, M2K 1E1

Research Site

Recruiting

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

Research Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

AstraZeneca

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.