Brenipatide for adults with moderate-to-severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 study, adults with moderate-to-severe COPD will receive Brenipatide at varying dose levels or placebo for about one year to evaluate safety and how well the drug works in improving COPD symptoms and lung function. Participants will continue their standard COPD therapies as background treatment. The trial uses a randomized, controlled design with placebo as a comparison and will monitor adverse events, lung function, and symptom changes. Locations include sites in Alabama, California, and beyond, enrolling patients with a history of smoking and recent COPD exacerbations.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• NewportNativeMD, Inc.
  Newport Beach, California, United States Recruiting
• Institute of HealthCare Assessment d/b/a Apex Clinical Research
  San Diego, California, United States Recruiting
• National Jewish Health Medical Center
  Denver, Colorado, United States Recruiting
• Millennium Medical Research - Miami
  Miami, Florida, United States Recruiting
• Deluxe Health Center
  Miami Lakes, Florida, United States Recruiting

+77 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ensa?fentrine to help prevent COPD flare-ups in adults on standard care

  This study tests whether ensifentrine (MK-5884) can help prevent moderate or severe COPD exacerbations compared with placebo in adults already receiving standard COPD treatment.

  Recruiting at 7 sites Phase 3 Merck Sharp & Dohme LLC · Hialeah Gardens, Florida and 6 other locations · NCT07874815

• GSK Investigational Medicine GSK3862995B: two formulations in healthy adults

  This early-phase study tests two formulations of GSK3862995B in healthy adults to see how the body handles the drug and whether it is safe and tolerable.

  Recruiting Phase 1 GlaxoSmithKline · Cambridge · NCT07789899

• GSK5784283 added to standard COPD therapy vs placebo in moderate to very severe COPD

  This study tests whether adding GSK5784283 to current COPD treatment reduces the rate of COPD flare-ups in adults with eosinophilic COPD and a history of exacerbations.

  Recruiting at 7 sites Phase 3 GlaxoSmithKline · Doral, Florida and 6 other locations · NCT07780669

• GSK5784283 added to standard COPD care versus placebo in adults with moderate to very severe COPD

  This study tests whether adding GSK5784283 to a patient’s current COPD treatment helps reduce COPD flare-ups compared with a placebo in adults with eosinophilic COPD and a history of frequent exacerbations.

  Recruiting at 8 sites Phase 3 GlaxoSmithKline · Cape Coral, Florida and 7 other locations · NCT07780656

• Early depemokimab treatment for COPD with type 2 (eosinophilic) inflammation

  This trial will test whether adding depemokimab early to standard care helps adults with moderate-to-severe COPD who have type 2 (eosinophilic) inflammation.

  Recruiting at 121 sites Phase 3 GlaxoSmithKline · Newport Beach, California and 120 other locations · NCT07177339

• Depemokimab for adults with COPD and eosinophilic (type 2) inflammation

  This study will test whether adding depemokimab to usual inhaled therapy can reduce flare-ups and improve outcomes for adults (40–80) with moderate-to-severe COPD and high blood eosinophils.

  Recruiting at 193 sites Phase 3 GlaxoSmithKline · Sheffield, Alabama and 192 other locations · NCT06961214

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.