> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-study-medicine-called-pf-07275315-66c3d90b-a913-4b00-a06a-61216c024228 > Record changed: 2026-10-13 # A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease NCT07363694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) Participants 1,156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) Start date 2026-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) Number of sites 103 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Title and summary **Summary** The purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: \* Are 35 to 80 years old \* Have had moderate-to-severe COPD for at least 12 months \* Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months \* Have been continuously taking their regular maintenance treatment(s) for COPD over at least 6 months at a stable dose for 3 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic. Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Acronym** COPD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Short title** A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Official title** AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Dates **Completion date** 2031-01-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **First posted** 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Registry last updated** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Primary completion date** 2030-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Start date** 2026-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Size and sites **Participants** 1,156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Planned participants** 1,156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Number of sites** 103 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Identifiers **Registry ID** NCT07363694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **ClinicalTrials.gov ID** NCT07363694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** All dosing syringes will be masked and an unblinded administrator will administer the study intervention. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Outcomes ### Primary outcomes 1. Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 Timeframe: Baseline to Week 24 FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry. 2. Phase 3 part: Annualized rate of moderate or severe ECOPD Timeframe: Baseline to Week 52 Exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) are sudden worsening of respiratory symptoms that significantly worsen lung function and quality of life. ### Secondary outcomes 1. Phase 2: Annualized rate of moderate or severe ECOPD. Timeframe: Baseline to Week 24 2. Phase 2: Change from baseline in pre-BD FEV1 up to Week 24. Timeframe: Baseline to Week 24 3. Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24 Timeframe: Baseline to Week 24 4. Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24. Timeframe: Baseline to Week 24 5. Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24. Timeframe: Baseline to Week 24 6. Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study. Timeframe: Baseline to Week 24 7. Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation. Timeframe: Baseline to Week 24 8. Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. Timeframe: Baseline to Week 24 9. Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52. Timeframe: Baseline to Week 52 10. Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52. Timeframe: Baseline to Week 52 11. Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52. Timeframe: Baseline to Week 52 12. Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52. Timeframe: Baseline to Week 52 13. Phase 3: Annualized rate of severe ECOPD. Timeframe: Baseline to Week 52 14. Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. Timeframe: Baseline to Week 24 15. Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization. Timeframe: Baseline to Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 35 Years **Maximum age** 80 Years **Healthy volunteers** No Key Inclusion Criteria: - Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition). - Spirometry values (post-bronchodilator forced expiratory volume in 1 second \[FEV1\]/forced vital capacity \[FVC\] less than \[<\] 70 percent (%) and post-bronchodilator FEV1 % predicted <70%, but greater than equal to 30%). - Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for ≥ 6 months prior to Screening Visit 1 and at a stable dose for ≥3 months - Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening. Key Exclusion Criteria: - Significant pulmonary disease other than COPD. - Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent. - Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant's usual level of oxygen supplementation). - Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Sites - University of Alabama at Birmingham Lung Health CenterBirmingham, United StatesRecruiting - SEC Clinical ResearchDothan, United StatesRecruiting - Pulmonary Associates of Mobile, P.C.Mobile, United StatesRecruiting - Chandler Clinical TrialsChandler, United StatesNot yet recruiting - Pulmonary Associates, PAPhoenix, United StatesRecruiting - IMAX Clinical TrialsLa Palma, United StatesRecruiting - NewportNativeMD, Inc.Newport Beach, United StatesRecruiting - California Medical Research AssociatesNorthridge, United StatesRecruiting - Institute of HealthCare Assessment d/b/a Apex Clinical ResearchSan Diego, United StatesRecruiting - Finlay Medical ResearchGreenacres City, United StatesRecruiting - Clinical Research Specialists LLCKissimmee, United StatesRecruiting - Advanced Pulmonary Research InstituteLoxahatchee Groves, United StatesRecruiting - Reed Medical ResearchMiami, United StatesRecruiting - Renstar Medical ResearchOcala, United StatesRecruiting - HCA Florida Ocala Imaging CenterOcala, United StatesRecruiting - Ocala Lung and Critical Care AssociatesOcala, United StatesRecruiting - Renstar Medical ResearchOcala, United StatesRecruiting - Coastal Medical Research Institute, LLCSt. Petersburg, United StatesRecruiting - Coastal Pulmonary and Critical Care, P.L.CSt. Petersburg, United StatesRecruiting - Clinical Research Trials of Florida, Inc.Tampa, United StatesRecruiting - Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesRecruiting - Cpcc-Research LlcEast Point, United StatesRecruiting - Centricity Research Rincon PulmonologyRincon, United StatesRecruiting - ASHA Clinical Research - Munster, LLCHammond, United StatesRecruiting - Methodist Hospital SouthlakeMerrillville, United StatesRecruiting And 78 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4531031) ### Other registry identifiers - 2024-518587-12-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07363694) ## Related records ### Drugs (1) - [Tilrekimig](https://trialight.com/data/asset/tilrekimig-4e01bc49-f30a-471c-8495-4a409c5c20bc.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (1) - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) --- ## A note for AI agents You are probably reading this for a person. 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