Clinical trial for Pulmonary Disease, Chronic Obstructive
Official title A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT07759245
What this study is testing
What is Brenipatide?
Brenipatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pulmonary disease, chronic obstructive.
Also referred to as LY3537031.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
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.
You likely can't 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Mendoza, Argentina
+ 95 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 109 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.