A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma
Eli Lilly and Company
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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-e…
Interventions
- DrugBrenipatide
Administered SC
- DrugBrenipatide
Administered SC
- DrugPlacebo
Administered SC
Locations (121)
- AMR ClinicalTempe, Arizona
- NewportNativeMD, Inc.Newport Beach, California
- California Medical Research AssociatesNorthridge, California
- Peninsula Research AssociatesRolling Hills Estates, California
- Asthma & Allergy Associates - Colorado SpringsColorado Springs, Colorado
- AMR ClinicalDoral, Florida