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.
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.
An established diagnosis of occupational asthma
chronic respiratory infection
bronchiectasis
pulmonary fibrosis
Parallel
Brenipatide
DrugAdministered SC
Brenipatide
DrugAdministered SC
Placebo
DrugAdministered SC
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
To assess the asthma exacerbation rate.
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)
Change from Baseline in Patient Reported Health Outcomes
Time to First Exacerbation
Change from Baseline in Weekly Mean Rescue Medication Use
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