A Phase 2 interventional study of Placebo for AZD8965 and AZD8965 low dose in Idiopathic Pulmonary Fibrosis (IPF), sponsored by AstraZeneca. Recruiting at 198 sites in 23 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
Among 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States — 37 open to participants now, 52 under way, 8 of them phase 3. Idiopathic Pulmonary Fibrosis · United States.
Among the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, this one is the 26th largest by planned enrollment of the 188 interventional ones, is one of 16 that started in 2026, is one of 82 in phase 2, reaches primary completion later than 36 of the 51 other live ones, and was the 229th registered.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 359 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →37 of the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 86 Idiopathic Pulmonary Fibrosis studies recruiting now, 56 (65%) set no upper age limit and 8 (9%) stop at 75 or younger; 3 take children under 18; 15 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →236 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 16 started in 2026.
Median enrollment 61 across the 188 interventional studies, 450 across the 45 observational. Of the 169 that completed or were terminated, 85 (50%) have results posted.
134 of 236 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
AstraZeneca has 5 studies filed under Idiopathic Pulmonary Fibrosis — fewer than ten, so there is no comparison to draw.
15 of the studies in Idiopathic Pulmonary Fibrosis with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06238622Phase 3Boehringer IngelheimA Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast | 2027-04-28 |
| NCT07868419Phase 3Trevi TherapeuticsIdiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets | 2027-08 |
| NCT06736990Calluna Pharma ASA Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis | 2026-11 |
| NCT06853145University of VirginiaHyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis | 2026-12 |
| NCT03478553University of Colorado, DenverThe Genetics of Pulmonary Fibrosis | 2026-12-31 |
Among the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Placebo for AZD8965
AZD8965 low dose
AZD8965 medium dose
AZD8965 high dose
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
Time frame: at Week 24
Relationship between dose and clinical efficacy of AZD8965 at Week 24
Change from baseline in FVC (in mL)
Time frame: Week 24
Change from baseline in FVC at Week 24
Change from baseline in % predicted FVC
Time frame: Week 24
Change in rate of decline in FVC at Week 24
Change in rate of decline in FVC (in mL/week)
Time frame: Week 24
Number of participants with adverse events (AEs)
Number of participants with AEs
Time frame: Up to 25 weeks
Number of participants with serious adverse events (SAEs)
Number of participants with SAEs
Time frame: Up to 25 weeks
Number of participants with AEs leading to discontinuation
Number of participants with AEs leading to discontinuation
Time frame: Up to 25 weeks
Summary statistics to evaluate the PK of AZD8965
AZD8965 concentrations in plasma
Time frame: From baseline to Week 24
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 198 sites across 23 countries. Choose a country and city above to see the rest.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Sep 2028, 27 months after the start.
Of 63 industry-sponsored phase 2 interventional studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 48. This study's planned 27 months is close to that.
Counting every sponsor, half of 76 studies reached it within 30 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Idiopathic Pulmonary Fibrosis →