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NCT07219173
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Conditions: Asthma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 531
Sponsor: Eli Lilly and Company
Location: AMR Clinical Tempe Arizona
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07219173). StuddyBuddy aggregates publicly available trial information.