Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Emphysema, Chronic Bronchitis, Lung Disease
Brief 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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁) | Baseline through Week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment | Baseline through Week 52 |
| Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score | Baseline, Week 36, and Week 52 |
| Change from Baseline in Pre-BD FEV₁ | Baseline through Week 52 |
Countries
Argentina, Austria, Canada, China, Czechia, Denmark, France, Germany, Hungary, India, Japan, Mexico, Poland, Puerto Rico, Romania, South Korea, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed