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RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

This research study is looking for adults aged 18 to 75 who have moderate to severe asthma that isn't fully controlled by their current medication. The main aim is to investigate a new treatment called brenipatide. We'll be comparing it to a placebo (a dummy medicine with no active ingredients) to see how safe and effective it is at different doses. The study will look at whether brenipatide can help reduce asthma flare-ups and improve breathing. Participation involves regular visits over approximately 65 weeks, including screening, treatment with either brenipatide or the placebo, and follow-up checks.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Eli Lilly and Company
Enrolment target
531
Start
22 Oct 2025
Estimated completion
01 Jun 2028

What is this study about?

This study is about a new potential medicine called brenipatide, which researchers hope might help people with asthma that is currently difficult to manage. If you have asthma that is moderate to severe and still causes problems even with your usual inhalers, this study might be relevant to you. The goal is to find out if brenipatide can make a real difference in controlling asthma symptoms and preventing severe asthma attacks.

Researchers will be carefully checking the safety of brenipatide. They will also be looking at how well it works compared to a placebo. A placebo is like a dummy treatment that doesn't contain any active medicine. This helps the researchers truly understand if any changes in asthma are due to brenipatide or other reasons. By using different doses of brenipatide, they also hope to find the most effective amount.

Finding new ways to manage asthma is very important because it can significantly improve people's lives. This study is a crucial step in understanding whether brenipatide could become a new option for people struggling with their asthma.

Key takeaways

  • The study is for adults (18-75) with moderate to severe, uncontrolled asthma.
  • It's testing a new medicine called brenipatide against a dummy medicine (placebo).
  • The aim is to check the medicine's safety and how well it improves asthma.
  • Participation lasts about 65 weeks, with regular clinic visits.
  • You might receive the new medicine or the placebo; you won't know which one.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old who has been diagnosed with asthma by a doctor. Your asthma needs to be moderate to severe and you should have been using a regular asthma controller medicine for at least 12 months. Also, your asthma control score (ACQ-6) needs to be above a certain level at two out of three visits before the study fully begins, showing that your asthma isn't fully under control. Crucially, you must have had at least one severe asthma attack in the past year that required steroid tablets.

There are also reasons why you might not be able to join. For example, if you have asthma caused by your job, or another significant lung condition that isn't asthma, such as emphysema, chronic bronchitis, or certain infections. If you have any other conditions that doctors might confuse with asthma, like vocal cord problems, you wouldn't be able to take part. Also, if you currently have a serious infection, or have had one recently (within 30 days before screening), you wouldn't be able to join.

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 18 and 75 years old?
  2. Have you been diagnosed with asthma by a doctor?
  3. Have you been using a regular asthma inhaler for at least a year?
  4. Did you have at least one severe asthma attack needing steroid tablets in the last year?
  5. Do you not have other serious lung conditions, apart from your asthma?
  6. Are you currently free from any active/serious infections?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for about 65 weeks in total. This includes a starting period where we check if you're suitable (screening), a time when you'll receive the study medicine, and a follow-up period after the treatment ends. You'll have regular visits to the clinic where you'll have check-ups, answer questions about your asthma, and have some tests done. You'll either receive brenipatide, the new medicine, or a placebo (a dummy medicine). You won't know which one you're getting. Doctors and nurses will monitor your health and breathing closely throughout the study.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medicine that might help your asthma if current treatments aren't fully effective. You would also have very close medical monitoring. However, there are also potential risks, as brenipatide is an experimental medicine and its side effects aren't fully known. You might experience side effects that could be mild or more serious, and there's no guarantee the medicine will help your asthma. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (122)

  • AMR Clinical
    Verified postcode
    Tempe, United States· Recruiting
  • NewportNativeMD, Inc.
    Verified postcode
    Newport Beach, United States· Recruiting
  • California Medical Research Associates
    Verified postcode
    Northridge, United States· Recruiting
  • Peninsula Research Associates
    Verified postcode
    Rolling Hills Estates, United States· Recruiting
  • Asthma & Allergy Associates - Colorado Springs
    Verified postcode
    Colorado Springs, United States· Recruiting
  • AMR Clinical
    Verified postcode
    Doral, United States· Recruiting
  • Renstar Medical Research
    Verified postcode
    Ocala, United States· Recruiting
  • Avanza Medical Research Center
    Verified postcode
    Pensacola, United States· Recruiting
  • USF Health
    Verified postcode
    Tampa, United States· Recruiting
  • Axis Clinical Trials - Westchester
    Verified postcode
    Westchester, United States· Recruiting
  • Allergy & Asthma Specialists, P.S.C.
    Verified postcode
    Owensboro, United States· Recruiting
  • Brigham and Women's Hospital
    Verified postcode
    Boston, United States· Recruiting

Common questions

What is brenipatide?

Brenipatide is a new medicine being tested in this study to see if it can help adults whose asthma is not well-controlled.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study medicine but contains no active ingredients. It helps researchers compare how well the new medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know whether you're receiving brenipatide or the placebo. This is a common practice in studies to ensure fair results.

How long will I be in the study?

Your participation will last for approximately 65 weeks, which is about 15 months.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your future medical care.

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 to Evaluate Brenipatide Compared With Placebo in Adu…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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