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

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: Moderate to Severe Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: PF-07275315 dose 1; Drug: PF-07275315-dose 2; Drug: Placebo; Drug: PF-07275315-dose 3

• Study Type: Interventional
• Enrollment (Estimated): 1156
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8X 1T3
      • Recruiting
      • Dr. Syed Anees Medicine Professional Corporation
• Japan
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 819-8555
      • Not yet recruiting
      • Nishifukuoka Hospital
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Not yet recruiting
      • SEC Clinical Research
    • Mobile, Alabama, United States, 36608
      • Not yet 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
      • Not yet recruiting
      • IMAX Clinical Trials
    • Newport Beach, California, United States, 92663
      • Recruiting
      • NewportNativeMD, Inc.
    • Northridge, California, United States, 91324
      • Not yet recruiting
      • California Medical Research Associates
    • San Diego, California, United States, 92120
      • Recruiting
      • Institute of HealthCare Assessment d/b/a Apex Clinical Research
  • Florida
    • Loxahatchee Groves, Florida, United States, 33470
      • Recruiting
      • Advanced Pulmonary Research Institute
    • Miami, Florida, United States, 33176
      • Recruiting
      • Reed Medical Research
    • St. Petersburg, Florida, United States, 33704
      • Not yet recruiting
      • Coastal Medical Research Institute, LLC
    • St. Petersburg, Florida, United States, 33704
      • Not yet recruiting
      • Coastal Pulmonary and Critical Care, P.L.C
  • 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
      • Not yet recruiting
      • ASHA Clinical Research - Munster, LLC
    • Merrillville, Indiana, United States, 46410
      • Not yet recruiting
      • Methodist Hospital Southlake
  • 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
    • Southfield, Michigan, United States, 48075
      • Recruiting
      • Revive Research Institute, Inc.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Not yet 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
      • Not yet recruiting
      • Health Concepts
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • Recruiting
      • Premier Research Center, LLC
  • Texas
    • Sherman, Texas, United States, 75090
      • Not yet recruiting
      • Sherman Clinical Research

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

5

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	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	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.	Baseline to Week 24
Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.	Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up 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.	Baseline to Week 24
Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24.	Baseline to Week 24
Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.	Baseline to Week 24
Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation.	Baseline to Week 24
Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.	Baseline to Week 24
Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and 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.	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.	Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52.	Baseline to Week 52
Phase 3: Annualized rate of severe ECOPD.	Baseline to Week 52
Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.	Baseline to Week 24
Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.	Baseline to Week 52

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• 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