Study of Brenipatide (LY3537031) in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

Chronic Obstructive Pulmonary Disease (COPD) is a long‑term lung condition that makes breathing difficult because the airways become narrowed and the lungs lose elasticity. People with moderate‑to‑severe COPD often experience shortness of breath, coughing, and reduced ability to do everyday activities. The study tests an investigational drug called Brenipatide, identified by the code LY3537031, which is given as a small injection under the skin (subcutaneous use). A matching placebo that looks the same but contains no active medication is also used for comparison.

The purpose of the study is to determine whether Brenipatide can improve lung function compared with placebo in adults with COPD. Lung function is mainly assessed by measuring the change from the start of the trial in the amount of air a person can force out of the lungs in one second, known as Forced Expiratory Volume in 1 Second (FEV1). This measurement helps to understand how well the lungs are working.

Participants will be randomly assigned to receive either the study drug or placebo for approximately one year, with regular clinic visits to receive the injection, monitor health, and check for any side effects. Throughout the study, safety checks and simple breathing tests will be performed to gather information on how the treatment affects the disease.

1 randomization and first dose

after joining the study you will be assigned by chance to receive either brenipatide or a matching placebo. the assignment is randomized and double‑blind, meaning neither you nor the study staff will know which product you receive.

you will receive a pre‑filled syringe containing a subcutaneous injection (injection under the skin). the exact amount of medication is defined by the study protocol and will be administered according to the schedule that follows.

2 regular medication administration

you will continue to receive the injection at regular intervals for the entire 52‑week treatment period. each injection will be given using the same pre‑filled syringe and the same subcutaneous route.

the frequency (for example, weekly or monthly) and the total duration are specified by the study protocol and will be followed throughout the 52 weeks.

3 periodic safety and lung‑function assessments

throughout the treatment period you will attend scheduled clinic visits. during these visits the study team will check your overall health, record any side effects, and perform tests of lung function.

the main lung‑function test is called fev1, which measures how much air you can force out of your lungs in one second. this measurement helps determine how the medication is affecting your breathing.

4 final visit and end of treatment

at the end of week 52 you will have a final study visit. the study medication will be stopped, and final safety checks and lung‑function tests will be performed.

the results of these assessments will be used to evaluate the overall effect of brenipatide compared with the placebo.

Who Can Join the Study?

  • Have a doctor’s diagnosis of chronic obstructive pulmonary disease (COPD) that was made at least 12 months before screening.
  • Be a current or former smoker with a smoking history of at least 10 pack‑years (one pack‑year equals smoking one pack per day for one year).
  • Have moderate‑to‑severe COPD, shown by a post‑bronchodilator FEV₁/FVC ratio less than 70% (FEV₁ = the amount of air you can force out in one second; FVC = the total amount of air you can force out).
  • Score 2 or higher on the Modified Medical Research Council Dyspnea Scale, a questionnaire that rates shortness of breath.
  • Have experienced at least two moderate or at least one severe COPD exacerbations (flare‑ups) in the year before joining the study.
  • Be using stable COPD medication for at least one month, either a double therapy of a long‑acting β₂‑agonist (LABA) plus a long‑acting muscarinic antagonist (LAMA) or a triple therapy that also includes an inhaled corticosteroid (ICS), and have been on this regimen for at least three months.
  • Be 18 years of age or older (an adult).
  • Be male or female; both genders are accepted.

Who Cannot Join the Study?

  • If you already have another pre‑existing (already existing) and clinically important (significant enough to affect health) lung condition besides COPD (chronic obstructive pulmonary disease), you cannot take part in the study.
  • If you have a current or recent acute (sudden and severe) active infection (an infection that is happening now) at the time of screening or up to the day you are assigned to the study (randomization), you cannot take part in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bispebjerg Hospital Copenhagen Denmark
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Framol-Med GmbH Rheine Germany
Vejle Sygehus Vejle Denmark
Esbjerg Sygehus Esbjerg Denmark
Aarhus Universitets hospital Aarhus Denmark
Sjællands Universitetshospital, Roskilde Roskilde Denmark
Aalborg University Hospital, Syd Aalborg Denmark
Diamond Clinic Sp, z o.o. Cracow Poland
Centrum Badan Klinicznych USK Bialystok Poland
Centrum Medyczne ALL-MED Badania Kliniczne Cracow Poland
Salvus – Klinische Studien GmbH Leipzig Germany
Studienzentrum Dr. Keller Frankfurt Germany
Hopital Cochin Paris France
Hopital Henri Mondor Creteil France
Chz Cviou Rlbqzjtwwlw Lyon France
Mrhminmqp svkyis Jindřichův Hradec Czechia
Mw Cjpxldnv Rzuylypvqha Ryjjivnv Hpwtfia Gqlk Hamburg Germany
Olmrenzl cnufmw puwejooq swrxdi Prague Czechia
Cqjpmm Hzasavyaauw Ufliuqcitwxtl Dy Mnuofhslnye Montpellier France
Cqpz Dp Nztsu Vandoeuvre Les Nancy France
Cvtvjj Hyrrctugppr Dd Cvxrwd Cholet France
Hhserph Einybaot Mghpncnxj Marseille France
Hxipucwj Hgahdxlq Hvidovre Denmark
Cqk Oacrzsr sbsyus Moravska Ostrava A Privoz Czechia
Ivh Ptzinbtdpyk Gdwr &dkfh Cgo Kh Frankfurt Germany
Mfybq Idyuz Pnmjqdmse sqeeat Miroslav Czechia
Axjkknxjo Muv Brjfef Gnfr Landsberg Am Lech Germany
Bxhvdn &eaox Myst Cwh Kyya Budapest Hungary
Bgcnepenj Uxdnic Uycgw Knibel Budapest Hungary
Kopt Rinkiy Kumfgm Ew Rffkpnyetivmvb Edeleny Hungary
Eiovvfut Gvzrbkyzmg Kknl Godollo Hungary
Iojwugxbk Kanj Pecs Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
18.06.2026
Denmark Denmark
Not yet recruiting
18.06.2026
France France
Not yet recruiting
18.06.2026
Germany Germany
Not yet recruiting
18.06.2026
Hungary Hungary
Not yet recruiting
18.06.2026
Poland Poland
Recruiting
18.06.2026

Trial locations

Investigated Drugs:

Brenipatide is an experimental medicine being studied to see if it can help improve breathing in adults with moderate‑to‑severe chronic obstructive pulmonary disease (COPD). In this trial, participants receive the drug as a liquid that is injected under the skin using a pre‑filled syringe. Researchers are comparing how well Brenipatide works to a placebo in order to determine its effect on lung function and overall safety over a 52‑week period.

Chronic obstructive pulmonary disease – Chronic obstructive pulmonary disease (COPD) is a long‑lasting lung condition that makes it hard to breathe. It usually starts with a cough and increased mucus production, and the airways become narrowed over time. The disease causes the lungs to lose their ability to move air in and out efficiently, leading to a gradual decline in breathing capacity. As COPD progresses, everyday activities can become more difficult because the lungs cannot supply enough oxygen.

Trial ID:
2026-525480-41-00
Protocol code:
J2S-MC-GZMV
Trial Phase:
Therapeutic exploratory (Phase II)

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