Brenipatide for Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called brenipatide to determine its safety and effectiveness for people with moderate-to-severe asthma. Participants will receive one of two different doses of brenipatide or a placebo (a substance with no active medication) through an injection under the skin. It targets individuals diagnosed with asthma who struggle to control their symptoms, even while on medication, including those who experienced a severe flare-up in the past year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important asthma research.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications. However, since participants must have been on asthma medication for at least 12 months, it seems likely you can continue your current asthma treatment.
Is there any evidence suggesting that brenipatide is likely to be safe for humans?
Research shows that brenipatide is being tested for safety in people with moderate-to-severe asthma. Researchers have tested different doses to identify any side effects, aiming to ensure the treatment is both effective and safe.
As brenipatide is in a phase 2 trial, early evidence from previous studies provides some insight into its safety. This phase focuses on determining the right dose and assessing how well participants tolerate the treatment. Although specific side effects are not detailed, ongoing research emphasizes safety as a primary concern.
Participants in such trials often report any side effects they experience, aiding researchers in gathering more information. Prospective participants should discuss any observed side effects with the trial team before joining.12345Why do researchers think this study treatment might be promising?
Brenipatide is unique because it offers a fresh approach to treating asthma. Unlike standard treatments like inhaled corticosteroids and bronchodilators, which primarily address inflammation and bronchial constriction, Brenipatide targets specific pathways to potentially reduce asthma symptoms more effectively. Administered subcutaneously, it provides an alternative delivery method that could offer convenience and improved adherence for patients. Researchers are excited about Brenipatide because it could represent a new class of asthma therapy, potentially offering relief for those not fully managed by existing options.
What evidence suggests that brenipatide might be an effective treatment for asthma?
Research has shown that treatments like brenipatide, which participants in this trial may receive, can help improve asthma symptoms. Studies have found that medications affecting the GLP-1 receptor, which helps control body weight and blood sugar, reduce asthma flare-ups. One study found that people using a similar treatment needed fewer asthma medications. Additionally, significant weight loss, sometimes seen with these treatments, has been linked to better asthma control. These findings suggest that brenipatide might help manage asthma by reducing flare-ups and improving overall control.678910
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe asthma that isn't well-controlled with their current treatment. Participants will be involved in the study for about 65 weeks, which includes screening, receiving the treatment, and follow-up.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brenipatide or placebo subcutaneously for 52 weeks to assess asthma exacerbation rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brenipatide
Trial Overview
The trial is testing brenipatide at various doses to see if it's safe and works better than a placebo (a treatment with no active drug) in controlling symptoms of moderate-to-severe asthma.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Brenipatide administered SC.
Brenipatide administered subcutaneously (SC)
Placebo administered SC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Dual GIPR and GLP-1R agonist tirzepatide inhibits ...
Previous studies showed that over 10% bodyweight loss improved Asthma Control Questionnaire (ACQ) score in obese patients with severe asthma.
Real-world use and effectiveness of tirzepatide among ...
In the current study, individuals who persisted on tirzepatide for 6 months experienced mean weight reduction of 12.9 % at 6 months post-index, although most ...
Real‐world use and effectiveness of tirzepatide among ...
Mean weight reduction in the effectiveness cohort was 11.9% at 6 months post-index (≥5%: 85.8%; ≥10%: 61.5%). Conclusions. Real-world evidence ...
A Target Trial Emulation Using the TriNetX Networks - Sciety
For patients without T2DM, the use of tirzepatide was related to a lower risk of receiving antiasthmatic bronchodilators (HR = 0.860; 95% CI: ...
Asthma Exacerbations and Glucagon-Like Peptide-1 Receptor ...
Studies have shown evidence of reduced exacerbations in asthmatics treated with GLP-1 receptor agonists (GLP-1 RA).
A Study to Evaluate Brenipatide Compared With Placebo in ...
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with ...
Brenipatide for Uncontrolled Moderate to Severe Asthma
The study evaluates how well brenipatide works and checks for any side effects, ensuring the treatment is safe and beneficial. This approach ...
Brenipatide for Asthma · Recruiting Participants for Phase ...
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with ...
A Study to Evaluate Brenipatide Compared With Placebo in ...
Overview. The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in ...
A Study to Evaluate Brenipatide Compared With ... - Lilly Trials
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.