Testing Brenipatide for Moderate-to-Severe COPD in Adults
Tests brenipatide against placebo in adults with moderate-to-severe chronic obstructive pulmonary disease.
Key facts
- Who runs it
- Eli Lilly and Company
- Where
- Caguas and San Juan, Puerto RicoSee the 2 sitesAlso in 17 other countries, 126 sites
- Trial code
- Registry title
- A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 606 people, planned
- Started
- 7 Aug 2026
- Expected to end
- Nov 2028
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Brenipatide
- Placebo
- Standard of Care
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 75 with moderate-to-severe COPD who have had flare-ups and already use inhaled COPD medicines.
- Age
- 40 to 75 years
- Sex
- All sexes can join.
- Disease stage
- COPD diagnosed by a doctor at least 12 months before screening, moderate-to-severe, with FEV₁/FVC below 70% after bronchodilator and mMRC-DS grade 2 or higher.
- Earlier treatment
- Must have used two inhaled medicines (LABA + LAMA) or three (ICS + LABA + LAMA) for 3 months before randomization, at a stable dose for at least 1 month before screening.
Main reasons for not taking part
- Another important lung condition besides COPD
- A current or recent acute, active infection before screening and up to randomization
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in Puerto Rico
Also in 17 other countries, 126 sites
- San Juan Bautista School of Medicine - Clinical Research UnitCaguas, Puerto RicoContact: Edgardo Cartagena Ayala (principal investigator)Taking people
- BRCR Global Puerto RicoSan Juan, Puerto RicoContact: Maria Betancourt Quiles (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Brenipatide Dose 1Treatment being tested
Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).
Treatment: Brenipatide and Standard of Care
- Brenipatide Dose 2Treatment being tested
Brenipatide high dose administered SC in combination with SOC.
Treatment: Brenipatide and Standard of Care
- PlaceboPlacebo, for comparison
Placebo administered SC in combination with SOC.
Treatment: Placebo and Standard of Care
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Testing Brenipatide for Moderate-to-Severe COPD in AdultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07759245, who can take part
- Record updated
- 5 November 2026