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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
531
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
To assess the asthma exacerbation rate.
Time frame: Baseline to Week 52
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, Week 52
Change from Baseline in Patient Reported Health Outcomes
Time frame: Baseline, Week 52
Time to First Exacerbation
Time frame: Baseline to Week 52
Change from Baseline in Weekly Mean Rescue Medication Use
Time frame: Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 52
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Time frame: Baseline to Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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