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Not yet recruitingPHASE2INTERVENTIONAL

A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

This study is investigating a new medicine called Brenipatide (also known as LY3537031) for adults living with moderate to severe Chronic Obstructive Pulmonary Disease, often called COPD. We want to find out if Brenipatide is safe and effective in helping manage symptoms when compared to a 'placebo' – a dummy medicine with no active ingredients. Participants will also continue their usual COPD treatments. The study aims to test different doses of Brenipatide. It's expected to run for about one year, helping researchers understand if this new medicine could be a helpful option for people with COPD in the future.

At a glance

Status
Not yet recruiting
Phase
PHASE2
Sponsor
Eli Lilly and Company
Enrolment target
606
Start
01 Aug 2026
Estimated completion
01 Nov 2028

What is this study about?

This study is focused on people who have Chronic Obstructive Pulmonary Disease, or COPD, which is a common long-term lung condition that makes it hard to breathe. We are particularly interested in those with moderate to severe forms of the condition. The main goal is to test a new medicine called Brenipatide. We want to see if it's safe to use and if it can help improve symptoms, compared to a 'placebo' (a dummy pill or treatment that looks the same but has no active medicine).

Researchers will give some participants different strengths of Brenipatide, while others will receive the placebo. Everyone in the study will also continue their usual COPD medications. This allows us to fairly compare the effects of the new medicine against what people would normally be taking, plus the placebo effect.

By taking part, you would be helping us learn more about Brenipatide. If it proves to be safe and helpful, it could become a new treatment option for people living with COPD in the future. The study is expected to last for approximately one year.

Key takeaways

  • This study is for adults aged 40-75 with moderate to severe COPD.
  • It's testing a new medicine, Brenipatide, to see if it's safe and effective.
  • Participants will receive either Brenipatide or a dummy medicine (placebo), plus their usual COPD treatment.
  • The study involves regular clinic visits and tests over about one year.
  • Your participation could help develop new treatments for COPD.
  • You can leave the study at any time, for any reason.

Who may be eligible?

To be considered for this study, you would need to be an adult between 40 and 75 years old with a confirmed diagnosis of moderate to severe COPD. You must have been diagnosed with COPD at least a year ago. We're looking for people who are current or former smokers, with a smoking history equivalent to smoking at least 20 cigarettes a day for 10 years.

Your COPD should be making breathing quite difficult, to the point where it affects your daily life. Also, in the past year, you should have had at least two flare-ups (times when your symptoms got much worse and needed treatment) or one very serious flare-up. You must also be on a stable dose of your current COPD medicines (either a 'double' or 'triple' inhaler combination) for at least three months before the study starts.

There are also some reasons why you might not be able to join. For example, if you have another significant lung condition that isn't COPD, or if you have a current or recent active infection before the study begins, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 40 and 75 years old?
  2. Have you been diagnosed with COPD for at least a year?
  3. Are you a current or former smoker with a significant smoking history?
  4. Do you have moderate to severe COPD that affects your daily breathing?
  5. Have you had at least two COPD flare-ups, or one very serious one, in the past year?
  6. Are you currently on a stable dose of either double or triple inhaler therapy for your COPD?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in the study for about one year. During this time, you would have regular visits to the study clinic. At these visits, doctors and nurses would check your health, ask about your symptoms, and carry out some tests. These tests might include breathing tests to measure your lung function and blood tests.

You would receive either the new medicine, Brenipatide, or a placebo (a dummy medicine). Neither you nor your study doctor would know which one you are receiving. You would also continue taking your usual COPD medications as prescribed. The study team would carefully monitor how you are doing throughout this period. It's important to attend all scheduled visits so the researchers can gather all the necessary information.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving careful medical attention and regular check-ups by specialists. You would also be contributing to medical research that could help others with COPD in the future. However, there's no guarantee that Brenipatide will improve your condition, and you might receive the placebo. As with any medicine, Brenipatide could have side effects, which the study team would explain in detail. There are also some risks associated with the tests, like blood samples. The study team would monitor you closely for any issues. It's important to remember that joining is completely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (128)

  • University of Alabama at Birmingham
    Verified postcode
    Birmingham, United States
  • NewportNativeMD, Inc.
    Verified postcode
    Newport Beach, United States
  • Institute of HealthCare Assessment d/b/a Apex Clinical Research
    Verified postcode
    San Diego, United States
  • National Jewish Health Medical Center
    Verified postcode
    Denver, United States
  • Millennium Medical Research - Miami
    Verified postcode
    Miami, United States
  • Deluxe Health Center
    Verified postcode
    Miami Lakes, United States
  • Florida Institute For Clinical Research, LLC
    Verified postcode
    Orlando, United States
  • Axis Clinical Trials - Westchester
    Verified postcode
    Westchester, United States
  • Indiana University Health University Hospital
    Verified postcode
    Indianapolis, United States
  • IU Health Ball Memorial Hospital, Inc.
    Verified postcode
    Muncie, United States
  • Brigham and Women's Hospital
    Verified postcode
    Boston, United States
  • Revive Research Institute, Inc.
    Verified postcode
    Southfield, United States

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it difficult to breathe, often caused by long-term exposure to harmful gases or particles, like cigarette smoke.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers understand if any improvements are due to the new medicine itself or other factors.

Will I still take my usual COPD medicines?

Yes, if you join this study, you will continue to take your regular COPD medications exactly as your doctor has prescribed, alongside the study medicine or placebo.

How long does the study last?

The study is expected to last for approximately one year, during which you'll have regular visits to the clinic for check-ups and tests.

What does 'moderate to severe COPD' mean?

This refers to the stage of your COPD. Moderate to severe means your breathing difficulties are significant and likely impact your daily life, and you may experience flare-ups of your symptoms.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Brenipatide (LY3537031) in Adult Participants Wit…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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