A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Who can join
Ages 40 to 75 · All sexes
Full 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.
About the study
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.
What is being tested
- Brenipatide (drug)
- Placebo (drug)
- Standard of Care (drug)
Sponsor: Eli Lilly and Company · Participants: 606 · Started: Aug 7, 2026
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07759245
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.