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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• University of Alabama at Birmingham, Birmingham, Alabama, United States
• NewportNativeMD, Inc., Newport Beach, California, United States
• Institute of HealthCare Assessment d/b/a Apex Clinical Research, San Diego, California, United States
• National Jewish Health Medical Center, Denver, Colorado, United States
• Millennium Medical Research - Miami, Miami, Florida, United States
• Deluxe Health Center, Miami Lakes, Florida, United States
• Florida Institute For Clinical Research, LLC, Orlando, Florida, United States
• Axis Clinical Trials - Westchester, Westchester, Illinois, United States
• Indiana University Health University Hospital, Indianapolis, Indiana, United States
• IU Health Ball Memorial Hospital, Inc., Muncie, Indiana, United States
• Brigham and Women's Hospital, Boston, Massachusetts, United States
• Revive Research Institute, Inc., Southfield, Michigan, United States

+ 116 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07759245.