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RecruitingPhase 2

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests different doses of brenipatide in adults with moderate-to-severe COPD, a long-term lung disease that makes breathing hard. It compares brenipatide with a placebo (a treatment with no active drug) to see if it is safe and works as intended. The study lasts about one year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A doctor diagnosed you with COPD at least 12 months before screening.
  • You smoke now or used to smoke, with at least 10 pack-years of smoking. This equals one pack a day for 10 years, or a similar amount.
  • You have moderate-to-severe COPD. After medicine to open your airways, a breathing test must show an FEV₁/FVC ratio below 70%—a measure of how much air you can blow out in the first second.
  • You score 2 or higher on the study’s shortness-of-breath scale.
  • You had at least 2 moderate COPD flare-ups or 1 severe flare-up in the past year.
  • You have used two long-acting medicines to open your airways, with or without an inhaled steroid, for 3 months before being assigned a study treatment. Your dose must be unchanged for at least 1 month before screening.

Who can't join

  • You have another known, significant lung condition besides COPD.
  • You have a current or recent active infection before screening or during the time before being assigned a study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (18)

AL

CA

CO

  • National Jewish Health Medical Center · Denver, CO 80206Michael Wechsler · Principal investigatorMore trials in Denver

FL

IL

IN

MA

MI

MN

PA

TX

WA