Asthma
Conditions
Keywords
Incretin
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 last approximately 65 weeks, including screening, treatment, and follow-up periods.
Interventions
DRUGBrenipatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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-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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment | Baseline to Week 52 | To assess the asthma exacerbation rate. |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 52 |
| Change from Baseline in Patient Reported Health Outcomes | Baseline, Week 52 |
| Time to First Exacerbation | Baseline to Week 52 |
| Change from Baseline in Weekly Mean Rescue Medication Use | Baseline, Week 52 |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide | Baseline up to Week 52 |
| Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs) | Baseline to Week 52 |
Countries
Argentina, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Netherlands, Poland, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed