A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Eli Lilly and Company · NCT07219173
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 531
- US sites recruiting
- 16
- Study start
- October 22, 2025
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Brenipatide; Brenipatide; Placebo
Conditions: Asthma
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
AMR Clinical
Tempe, AZ 85281
Site contact: 6029103343
NewportNativeMD, Inc.
Newport Beach, CA 92663
Site contact: 9497918599
California Medical Research Associates
Northridge, CA 91324
Site contact: Sanjay Vadgama
Peninsula Research Associates
Rolling Hills Estates, CA 90274
Site contact: 3102651623
Asthma & Allergy Associates - Colorado Springs
Colorado Springs, CO 80907
Site contact: Luke Webb
AMR Clinical
Doral, FL 33172-2514
Site contact: Abid Chaudhry
Renstar Medical Research
Ocala, FL 34470
Site contact: 3526295800
Avanza Medical Research Center
Pensacola, FL 32503
Site contact: 8504777900
USF Health
Tampa, FL 33613
Site contact: 8136314024
Axis Clinical Trials - Westchester
Westchester, IL 60154
Site contact: Mohammad Ghani
Allergy & Asthma Specialists, P.S.C.
Owensboro, KY 42301
Site contact: 2706846144
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Dinah Foer
AMR Clinical
Las Vegas, NV 89119
Site contact: 702-597-9825
Equity Medical
New York, NY 10455
Site contact: (908) - 303-9909
University of Pittsburgh Medical Center
Pittsburgh, PA 15213
Site contact: 6309811261
Allergy and Clinical Immunology Associates
Pittsburgh, PA 15241
Site contact: 4128334051
Study contacts (from the official record)
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 317-615-4559 · LillyTrials@Lilly.com
- Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com