A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

June 15, 2026 updated by: Pfizer

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1156

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 0N2
        • Recruiting
        • Synergy Respiratory Care
    • Ontario
      • Windsor, Ontario, Canada, N8X 1T3
        • Recruiting
        • Dr. Syed Anees Medicine Professional Corporation
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Not yet recruiting
        • C.I.C. Mauricie inc.
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510150
        • Recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
    • Henan
      • Xinxiang, Henan, China, 453000
        • Not yet recruiting
        • The First People's Hospital of Xinxiang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 611130
        • Recruiting
        • Chengdu Fifth People's Hospital
  • India
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Recruiting
        • KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
    • Maharashtra
      • Thane, Maharashtra, India, 401107
        • Recruiting
        • Bhaktivedanta Hospital and Research Institute
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Not yet recruiting
        • Sir Ganga Ram Hospital
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Not yet recruiting
        • Jawahar Lal Nehru Medical College
      • Jaipur, Rajasthan, India, 302039
        • Recruiting
        • Maharaja Agrasen Superspeciality Hospital
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641028
        • Not yet recruiting
        • Hindusthan Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500068
        • Not yet recruiting
        • Kamineni Hospitals Private Limited
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Not yet recruiting
        • Shri Guru Ram Rai Institute of Medical & Health Sciences & Shri Mahant lndiresh Hospital
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8511
        • Not yet recruiting
        • Koujunkai Daido Clinic
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 819-8555
        • Recruiting
        • Nishifukuoka Hospital
      • Iizuka-shi, Fukuoka, Japan, 820-8505
        • Not yet recruiting
        • Aso Iizuka Hospital
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-8505
        • Recruiting
        • Kure Kyosai Hospital
    • Okinawa
      • Ginowan, Okinawa, Japan, 901-2214
        • Recruiting
        • National Hospital Organization Okinawa Hospital
    • Osaka
      • Sakai, Osaka, Japan, 591-8555
        • Not yet recruiting
        • NHO Kinki Chuo Chest Medical Center
    • Shizuoka
      • Fujieda, Shizuoka, Japan, 426-0077
        • Not yet recruiting
        • Fujieda Municipal General Hospital
    • Tokyo
      • Hachiōji, Tokyo, Japan, 1930998
        • Not yet recruiting
        • Tokyo Medical University Hachioji Medical Center
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Not yet recruiting
        • Yamaguchi University Hospital
  • South Korea
      • Seoul, South Korea, 03312
        • Not yet recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary'S Hospital
      • Seoul, South Korea, 06591
        • Not yet recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's hospital
    • Jeonbuk-do
      • Jeonju, Jeonbuk-do, South Korea, 54907
        • Recruiting
        • Jeonbuk National University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
  • Taiwan
      • Hsinchu, Taiwan, 302
        • Not yet recruiting
        • National Taiwan University Hospital - Hsinchu branch
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 220
        • Not yet recruiting
        • Far Eastern Memorial Hospital
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Taichung, Taiwan, 407219
        • Recruiting
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Medical Foundation-Linkou Branch
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Lung Health Center
      • Dothan, Alabama, United States, 36305
        • Recruiting
        • SEC Clinical Research
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Pulmonary Associates of Mobile, P.C.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Not yet recruiting
        • Chandler Clinical Trials
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • Pulmonary Associates, PA
    • California
      • La Palma, California, United States, 90623
        • Recruiting
        • IMAX Clinical Trials
      • Newport Beach, California, United States, 92663
        • Recruiting
        • NewportNativeMD, Inc.
      • Northridge, California, United States, 91324
        • Recruiting
        • California Medical Research Associates
      • San Diego, California, United States, 92120
        • Recruiting
        • Institute of HealthCare Assessment d/b/a Apex Clinical Research
    • Florida
      • Greenacres City, Florida, United States, 33467
        • Recruiting
        • Finlay Medical Research
      • Kissimmee, Florida, United States, 34746
        • Not yet recruiting
        • Clinical Research Specialists LLC
      • Loxahatchee Groves, Florida, United States, 33470
        • Recruiting
        • Advanced Pulmonary Research Institute
      • Miami, Florida, United States, 33176
        • Recruiting
        • Reed Medical Research
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
      • Ocala, Florida, United States, 34471
        • Recruiting
        • HCA Florida Ocala Imaging Center
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Ocala Lung and Critical Care Associates
      • St. Petersburg, Florida, United States, 33704
        • Recruiting
        • Coastal Medical Research Institute, LLC
      • St. Petersburg, Florida, United States, 33704
        • Recruiting
        • Coastal Pulmonary and Critical Care, P.L.C
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • East Point, Georgia, United States, 30344
        • Recruiting
        • Cpcc-Research Llc
      • Rincon, Georgia, United States, 31326
        • Recruiting
        • Centricity Research Rincon Pulmonology
    • Indiana
      • Hammond, Indiana, United States, 46324
        • Recruiting
        • ASHA Clinical Research - Munster, LLC
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • Methodist Hospital Southlake
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Not yet recruiting
        • Southern Clinical Research, LLC
    • Maine
      • Bangor, Maine, United States, 04401
        • Not yet recruiting
        • Paul A. Shapero, MD, PA
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Revival Research Institute, LLC
      • Flint, Michigan, United States, 48504
        • Recruiting
        • AA Medical Research Center
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Revive Research Institute, Inc.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital Investigational Drug Service
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School-Cardiovascular Imaging and Clinical Research Core Laboratory
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Henderson Clinical Trials
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Southeastern Research Center
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Salem Chest Specialists
    • Ohio
      • Toledo, Ohio, United States, 43617
        • Not yet recruiting
        • Toledo Institute of Clinical Research Inc.
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • Clinical Research Associates of Central PA, LLC
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • Recruiting
        • Velocity Clinical Research, Gaffney
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Velocity Clinical Research, Spartanburg
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • Health Concepts
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Clinical Trials Center of Middle Tennessee, LLC
      • Hendersonville, Tennessee, United States, 37075
        • Recruiting
        • Premier Research Center, LLC
    • Texas
      • Carrollton, Texas, United States, 75010
        • Recruiting
        • Ten20 Clinical Research
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Horizon Clinical Research Group
      • Dallas, Texas, United States, 75209
        • Recruiting
        • Alina Clinical Trials, LLC.
      • Houston, Texas, United States, 77008
        • Recruiting
        • Greater Heights & Memorial Pulmonary and Sleep
      • Houston, Texas, United States, 77065
        • Recruiting
        • Houston Pulmonary Sleep and Allergy Associates
      • Sherman, Texas, United States, 75090
        • Recruiting
        • Sherman Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2 Treatment Arm A
Drug: PF-07275315 dose 1
SC injection dose 1
Experimental: Phase 2 Treatment Arm B
Drug: PF-07275315-dose 2
SC injection dose 2
Placebo Comparator: Phase 2 Treatment Arm C
Drug: Placebo
SC injection matched
Experimental: Phase 3 Treatment Arm A
Drug: PF-07275315-dose 3
SC injection dose 3
Placebo Comparator: Phase 3 Treatment Arm B
Drug: Placebo
SC injection matched

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Time Frame: 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.
Baseline to Week 24
Phase 3 part: Annualized rate of moderate or severe ECOPD
Time Frame: 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.
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase 2: Annualized rate of moderate or severe ECOPD.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52.
Time Frame: Baseline to Week 52
Baseline to Week 52
Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52.
Time Frame: Baseline to Week 52
Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52.
Time Frame: Baseline to Week 52
Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52.
Time Frame: Baseline to Week 52
Baseline to Week 52
Phase 3: Annualized rate of severe ECOPD.
Time Frame: Baseline to Week 52
Baseline to Week 52
Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.
Time Frame: Baseline to Week 24
Baseline to Week 24
Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.
Time Frame: Baseline to Week 52
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2026

Primary Completion (Estimated)

October 24, 2030

Study Completion (Estimated)

January 16, 2031

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4531031
  • 2024-518587-12-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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