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A Study of Brenipatide Compared to Placebo for Adults with Uncontrolled Moderate to Severe Asthma

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What is this trial about?

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

This study is looking at people with asthma that is not well controlled, specifically those with moderate to severe asthma. Asthma is a condition where the airways in the lungs become narrow and swollen, making it difficult to breathe. The treatment being tested is called Brenipatide, which is also known by its code name LY3537031. This medication works by acting on certain receptors in the body that affect how the body handles sugar and may help reduce inflammation in the airways. Some people in the study will receive Brenipatide while others will receive placebo. The medication is given as an injection under the skin using a pre-filled syringe.

The purpose of the study is to find out if Brenipatide can help reduce severe asthma attacks compared to placebo. A severe asthma attack, also called an exacerbation, is when asthma symptoms suddenly get much worse and may require treatment with oral steroids or even a hospital visit. The study will measure how many severe asthma attacks happen over the course of the treatment period.

The study will last for 52 weeks, which is about one year. People taking part will be randomly assigned to receive either Brenipatide or placebo, and neither they nor their doctors will know which treatment they are getting during the study. Throughout the study, doctors will monitor how well the treatment works and check for any side effects. To join this study, people must have been diagnosed with asthma and have been taking asthma controller medication for at least 12 months, and they must have had at least one severe asthma attack that required oral steroid treatment in the past year.

The research process

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

Step 1
Initial assessment and randomization
Your diagnosis of asthma and treatment history will be confirmed. You must have been diagnosed with asthma and taking a controller medication prescribed by your doctor for at least 12 months.
Your medical history will be reviewed to confirm you had at least 1 severe asthma worsening that required treatment with oral steroids in the last 12 months.
You will be randomly assigned to receive either Brenipatide or placebo. The placebo is an inactive substance that looks identical to the study medication but contains no active ingredient.
Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind study design.
Step 2
Treatment period
You will receive either Brenipatide (active substance: ly3537031) or placebo for a total duration of 52 weeks.
The medication will be administered as an injection under the skin (subcutaneous injection).
The medication comes in a pre-filled syringe ready for injection.
You will continue taking your regular asthma controller medication as prescribed by your doctor throughout the study.
Step 3
Monitoring and assessments
Throughout the 52-week treatment period, your asthma symptoms and any worsening of asthma will be monitored.
The main focus will be on tracking how many times your asthma gets worse and requires additional treatment. These episodes are called severe asthma exacerbations.
Your doctor will assess your overall response to the treatment and any side effects you may experience.
Regular check-ups will be scheduled to evaluate your condition and ensure your safety during the study.
Step 4
Study completion
After completing the 52-week treatment period, your participation in the study will end.
Final assessments will be performed to evaluate the overall effect of the treatment on your asthma control.
Your doctor will discuss with you the next steps for managing your asthma after the study concludes.

Who can join the trial?

5 criteria

You must have been told by a doctor that you have asthma, which is a condition that makes it hard to breathe because your airways become narrow and swollen
You must have been taking asthma controller medication for at least 12 months before joining the study. These are medicines prescribed by your doctor that you take regularly to help prevent asthma symptoms
You must have had at least 1 severe asthma exacerbation in the last 12 months. This means your asthma got much worse suddenly, and you needed treatment with oral steroids, which are pills that help reduce swelling in your airways
You can be male or female
You must be an adult to participate in this study

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list specific medical conditions, medications, or circumstances that would prevent participation
Typically, exclusion criteria might include things like other serious illnesses, certain medications you are taking, pregnancy or breastfeeding, or recent participation in other studies, but these specific details are not available in the provided information

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Verified sites

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Responsive
Diamond Clinic Sp. z o.o.
Cracow, Poland
Recruiting
Responsive
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, Germany
Responsive
Sint Franciscus Vlietland Groep Stichting
Rotterdam, The Netherlands

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Investigated drugs

Brenipatide
is an investigational medication being studied for the treatment of moderate to severe asthma in adults whose condition is not well controlled. This medication is being tested to see if it can help reduce severe asthma attacks and improve breathing in people with asthma.
Placebo
is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against brenipatide to help determine if brenipatide truly works for treating asthma symptoms.

LY3537031

What is already known about the treatment

Brenipatide – Brenipatide is an investigational medication currently being studied in clinical trials for the treatment of uncontrolled moderate to severe asthma in adults. This drug is being tested to see if it can reduce severe asthma attacks, which are episodes when breathing problems suddenly get much worse and require urgent medical attention. The medication works by targeting specific molecules in the body that are involved in causing inflammation and narrowing of the airways in the lungs, though the exact mechanism is still being evaluated in ongoing research. Brenipatide is being compared against placebo (an inactive substance) in a 52-week study to determine its effectiveness and safety profile before it can be approved for general medical use.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition that affects the airways in the lungs. When a person has asthma, their airways become inflamed and narrow, making it difficult to breathe. The muscles around the airways can tighten, and the airways may produce extra mucus, further blocking airflow. Common symptoms include wheezing, shortness of breath, chest tightness, and coughing, especially at night or early morning. Asthma symptoms can vary in intensity and frequency, ranging from mild and occasional to severe and persistent. During asthma exacerbations, also called asthma attacks, symptoms suddenly worsen and breathing becomes significantly more difficult.