Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07363694

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Moderate to Severe Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

IDIM - Instituto de Investigaciones Metabólicas, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07275315 dose 1

Drug

SC injection dose 1

PF-07275315-dose 2

Drug

SC injection dose 2

Placebo

Drug

SC injection matched

PF-07275315-dose 3

Drug

SC injection dose 3

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Phase 2: Annualized rate of moderate or severe ECOPD.

    Time frame: Baseline to Week 24

  2. Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.

    Time frame: Baseline to Week 24

  3. Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24

    Time frame: 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.

    Time frame: Baseline to Week 24

  5. Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24.

    Time frame: Baseline to Week 24

  6. Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.

    Time frame: Baseline to Week 24

  7. Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation.

    Time frame: Baseline to Week 24

  8. Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.

    Time frame: Baseline to Week 24

  9. Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline to Week 52

  13. Phase 3: Annualized rate of severe ECOPD.

    Time frame: Baseline to Week 52

  14. Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.

    Time frame: Baseline to Week 24

  15. Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.

    Time frame: Baseline to Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Acronym: COPD

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 23, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.