Recruiting
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
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.
ClinicalTrials.gov IDNCT07219173
PhasePHASE2
Enrollment531
SponsorEli Lilly and Company
Age18 Years
SexALL
Conditions studied
Asthma
About this study
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
- Drug: Brenipatide — Administered SC
- Drug: Brenipatide — Administered SC
- Drug: Placebo — Administered SC
Primary outcomes
- Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment (Baseline to Week 52)
Eligibility information
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.
Study locations
- AMR Clinical, Tempe, Arizona 85281 United States
- NewportNativeMD, Inc., Newport Beach, California 92663 United States
- California Medical Research Associates, Northridge, California 91324 United States
- Peninsula Research Associates, Rolling Hills Estates, California 90274 United States
- Asthma & Allergy Associates - Colorado Springs, Colorado Springs, Colorado 80907 United States
- AMR Clinical, Doral, Florida 33172-2514 United States
- Renstar Medical Research, Ocala, Florida 34470 United States
- Avanza Medical Research Center, Pensacola, Florida 32503 United States
- USF Health, Tampa, Florida 33613 United States
- Axis Clinical Trials - Westchester, Westchester, Illinois 60154 United States
Showing 10 of 121 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.