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Recruiting Phase 2

A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT07759245 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2026-08-07
Last updated
2026-10-08

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

Brenipatide →PlaceboStandard of Care

Brenipatide: Brenipatide administered SC

Placebo: Placebo administered SC

Standard of Care: SOC

Study summary

The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria: * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)/forced vital capacity (FVC) less than (\<) 70 percent (%) * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2 * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion. * Background double therapy \[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\] or triple therapy \[inhaled corticosteroids (ICS) + LABA + LAMA)\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening. Exclusion Criteria: * Have a known pre-existing, clinically important lung condition other than COPD. * Have a current or recent acute, active infection before screening and up to randomization.

Primary outcome measure(s)

  • Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁) — Baseline through Week 36

Trial sites (127)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
NewportNativeMD, Inc. Newport Beach California Recruiting
Institute of HealthCare Assessment d/b/a Apex Clinical Research San Diego California Recruiting
National Jewish Health Medical Center Denver Colorado Not Yet Recruiting
Millennium Medical Research - Miami Miami Florida Recruiting
Deluxe Health Center Miami Lakes Florida Recruiting
Florida Institute For Clinical Research, LLC Orlando Florida Recruiting
Axis Clinical Trials - Westchester Westchester Illinois Recruiting
Indiana University Health University Hospital Indianapolis Indiana Recruiting
IU Health Ball Memorial Hospital, Inc. Muncie Indiana Recruiting
Brigham and Women's Hospital Boston Massachusetts Not Yet Recruiting
Revive Research Institute, Inc. Southfield Michigan Recruiting
Headlands Research-Twin Cities Maplewood Minnesota Recruiting
Clinical Research Associates of Central PA DuBois Pennsylvania Recruiting
Premier Pulmonary Critical Care and Sleep Denison Texas Not Yet Recruiting
Baylor College of Medicine Medical Center Houston Texas Not Yet Recruiting
Prime Clinical Research - Lewisville Lewisville Texas Recruiting
Paramount Clinical Research - Data Point Clinical Research Kirkland Washington Recruiting
Consultorios Médicos, Organización del Buen Ayre S.R.L. Buenos Aires Argentina Recruiting
Centro Médico Viamonte Buenos Aires Argentina Recruiting
Fundación Respirar Buenos Aires Argentina Recruiting
Fundacion Scherbovsky Mendoza Argentina Recruiting
Instituto Médico Río Cuarto Río Cuarto Argentina Recruiting
Centro de Salud e Investigaciones Médicas Santa Rosa Argentina Recruiting
Private Practice - Dr. Robert Voves Feldbach Austria Not Yet Recruiting
Klinikum Klagenfurt am Wörthersee Klagenfurt Austria Not Yet Recruiting
Ordination für Lungenkrankheiten Linz Austria Not Yet Recruiting
Klinik Floridsdorf Vienna Austria Not Yet Recruiting
Dynamic Drug Advancement Ajax Canada Not Yet Recruiting
Kelowna Health and Memory Centre Kelowna Canada Recruiting
Diex Recherche Inc. Division Sherbrooke Est Sherbrooke Canada Recruiting
Inspiration Research Toronto Canada Not Yet Recruiting
C.I.C. Mauricie inc. Trois-Rivières Canada Not Yet Recruiting
Dr. Syed Anees Medicine Professional Corporation Windsor Canada Recruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T Baotou China Not Yet Recruiting
China-Japan Friendship Hospital Beijing China Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu China Not Yet Recruiting
The First Affiliated Hospital of Guangzhou Medical University Guangzhou China Not Yet Recruiting
Jiangyin People's Hospital Jiangyin China Not Yet Recruiting
Jinan Central Hospital Jinan China Not Yet Recruiting

+ 87 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07759245 on ClinicalTrials.gov ↗ ← All trials in Canada