A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Mod… (NCT07219173) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
United States, Argentina, Brazil531 participantsStarted 2025-10-22
Plain-language summary
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.
Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
* Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
* History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.
Exclusion Criteria:
* Participants are excluded from the study if any of the following criteria apply:
* An established diagnosis of occupational asthma
* Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
* chronic respiratory infection
* bronchiectasis
* pulmonary fibrosis
* allergic bronchopulmonary aspergillosis
* emphysema
* chronic bronchitis
* eosinophilic granulomatosis with polyangiitis
* chronic obstructive pulmonary disease, and
* other mimics of asthma, that is, vocal cord dysfunction.
* Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for brenipatide, what do we currently know about its safety profile, and what risks might I be taking on compared to treatments that already have years of real-world data?
2The trial uses a placebo comparison, which means I could be assigned to a group that doesn't receive the active drug — given how uncontrolled my asthma is right now, is it safe for me to potentially go 52 weeks without a new active treatment?
3This study measures asthma exacerbation rates over a full year — does that timeline work with my current health situation, and what happens if my asthma gets significantly worse during the study?
4Before considering this trial, are there approved biologics or other treatments for moderate to severe uncontrolled asthma that I haven't tried yet, and would it make more sense to explore those first?
5If I enroll and brenipatide doesn't seem to be helping me, what are my options for leaving the trial and transitioning back to standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
Timeframe: Baseline to Week 52
Trial details
NCT IDNCT07219173
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-04
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or