Status:
RECRUITING
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT07219173
Start Date
October 22 2025
End Date
June 1 2028
Last Update
December 18 2025
Active Locations (120)
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1
AMR Clinical
Tempe, Arizona, United States, 85281
2
NewportNativeMD, Inc.
Newport Beach, California, United States, 92663
3
California Medical Research Associates
Northridge, California, United States, 91324
4
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274