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

NCT07759245

Not Yet RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Brenipatide, Placebo, Standard of Care

Countries: United States, Argentina, Austria, Canada, China, Czechia, Denmark, France

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 overview

Sex: ALL

Age: 40 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (128)
  • Birmingham, Alabama, United States
  • Newport Beach, California, United States
  • San Diego, California, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Westchester, Illinois, United States
  • Indianapolis, Indiana, United States
  • Muncie, Indiana, United States
  • Boston, Massachusetts, United States
  • Southfield, Michigan, United States
  • Maplewood, Minnesota, United States
  • DuBois, Pennsylvania, United States
  • Denison, Texas, United States
  • Houston, Texas, United States
  • Lewisville, Texas, United States
  • Kirkland, Washington, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Mendoza, Argentina
  • Río Cuarto, Argentina
  • Santa Rosa, Argentina
  • Feldbach, Austria
  • Klagenfurt, Austria
  • Linz, Austria
  • Vienna, Austria
  • Kelowna, Canada
  • Sherbrooke, Canada
  • + 98 more on CT.gov