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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

2 criteria

  • 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.
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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.

What is already known about the treatment

  • Brenipatide

    Brenipatide is supplied as a clear solution for injection in a pre‑filled syringe and is given by subcutaneous (under the skin) injection. It is an investigational drug that is currently being studied in clinical trials and has not yet received regulatory approval. The medication is being tested for the treatment of moderate‑to‑severe chronic obstructive pulmonary disease (COPD) and works by binding to specific receptors in the lungs to help improve airflow and reduce inflammation. It belongs to the class of experimental peptide therapies.

  • Placebo to match Test

    The placebo is a sterile solution that looks identical to the Brenipatide injection but contains no active drug substance. It is used only as a control in the clinical study and has no therapeutic effect. The purpose of the placebo is to help researchers compare the safety and effectiveness of Brenipatide against an inert substance. It is classified as an inert control agent.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525480-41-00Protocol codeJ2S-MC-GZMVEstimated enrolment606 patientsSponsorEli Lilly & Co.

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