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A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
NCT07219173 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
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.
Eligibility 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.
Study design
Enrollment target: 531 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-10-22
Estimated completion: 2028-06
Last updated: 2026-04-17
Interventions
Drug: BrenipatideDrug: BrenipatideDrug: Placebo
Primary outcomes
- • Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment (Baseline to Week 52)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (121)
AMR ClinicalRecruiting
Tempe, Arizona, United States
NewportNativeMD, Inc.Recruiting
Newport Beach, California, United States
California Medical Research AssociatesRecruiting
Northridge, California, United States
Peninsula Research AssociatesRecruiting
Rolling Hills Estates, California, United States
Asthma & Allergy Associates - Colorado SpringsRecruiting
Colorado Springs, Colorado, United States
AMR ClinicalRecruiting
Doral, Florida, United States
Renstar Medical ResearchRecruiting
Ocala, Florida, United States
Avanza Medical Research CenterRecruiting
Pensacola, Florida, United States
USF HealthRecruiting
Tampa, Florida, United States
Axis Clinical Trials - WestchesterRecruiting
Westchester, Illinois, United States
Allergy & Asthma Specialists, P.S.C.Recruiting
Owensboro, Kentucky, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
AMR ClinicalRecruiting
Las Vegas, Nevada, United States
Equity MedicalRecruiting
New York, New York, United States
University of Pittsburgh Medical CenterNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Allergy and Clinical Immunology AssociatesRecruiting
Pittsburgh, Pennsylvania, United States
Vanderbilt Asthma, Sinus and Allergy ProgramNot Yet Recruiting
Nashville, Tennessee, United States
Consultorios Médicos, Organización del Buen Ayre S.R.L.Not Yet Recruiting
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)Not Yet Recruiting
Buenos Aires, Argentina
Fundación RespirarNot Yet Recruiting
Buenos Aires, Argentina
IDIM - Instituto de Investigaciones MetabólicasNot Yet Recruiting
Ciudad de Buenos Aires, Argentina
Instituto de Asma, Alergia y Enfermedades RespiratoriasNot Yet Recruiting
Corrientes, Argentina
Centro de Investigaciones Clínicas BaigorriaNot Yet Recruiting
Granadero Baigorria, Argentina
Instituto de Investigaciones Clínicas Mar del PlataNot Yet Recruiting
Mar del Plata, Argentina
Instituto Médico Río CuartoNot Yet Recruiting
Río Cuarto, Argentina
ABC Instituto de DiagnósticoNot Yet Recruiting
Rosario, Argentina
IbamedicaNot Yet Recruiting
Santa Fe, Argentina
NewData Clinical Research - AracajuNot Yet Recruiting
Aracaju, Brazil
Private Practice - Dr. Nelson RosárioNot Yet Recruiting
Curitiba, Brazil
Clinica de PneumologiaNot Yet Recruiting
Goiânia, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMNot Yet Recruiting
Marília, Brazil
Hospital Universitário Onofre LopesNot Yet Recruiting
Natal, Brazil
Instituto Atena de Pesquisa ClinicaNot Yet Recruiting
Natal, Brazil
Instituto Méderi de Pesquisa e SaúdeNot Yet Recruiting
Passo Fundo, Brazil
Hospital de Clínicas de Ribeirão PretoNot Yet Recruiting
Ribeirão Preto, Brazil
IBPClin - Instituto Brasil de Pesquisa ClínicaNot Yet Recruiting
Rio de Janeiro, Brazil
Clinica de Alergia Martti AntilaNot Yet Recruiting
Sorocaba, Brazil
Dynamic Drug AdvancementRecruiting
Ajax, Canada
Heritage Medical Research ClinicNot Yet Recruiting
Calgary, Canada
University Of Alberta HospitalSuspended
Edmonton, Canada
St. Joseph's Healthcare HamiltonNot Yet Recruiting
Hamilton, Canada
Kelowna Health and Memory CentreRecruiting
Kelowna, Canada
McGill University Health CentreNot Yet Recruiting
Montreal, Canada
IUCPQNot Yet Recruiting
Québec, Canada
Richmond Clinical TrialsRecruiting
Richmond, Canada
C.I.C. Saint-LaurentRecruiting
Saint-Laurent, Canada
Inspiration ResearchNot Yet Recruiting
Toronto, Canada
Dr. Syed Anees Medicine Professional CorporationRecruiting
Windsor, Canada
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -TRecruiting
Baotou, China
Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
Beijing, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, China
Zhejiang Provincial People's HospitalRecruiting
Hangzhou, China
Jiangxi Provincial People's HospitalRecruiting
Nanchang, China
Nanjing Medical University - Nanjing Jiangning HospitalRecruiting
Nanjing, China
Shanghai General HospitalRecruiting
Shanghai, China
The University of Hong Kong-Shenzhen HospitalRecruiting
Shenzhen, China
The Second Afilliated Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, China
Tianjin Medical University General HospitalRecruiting
Tianjin, China
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Wuhan, China
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en ProvenceRecruiting
Aix-en-Provence, France
CHRU de BrestRecruiting
Brest, France
Centre Hospitalier de CholetRecruiting
Cholet, France
Centre Hospitalier de Versailles André MignotNot Yet Recruiting
Le Chesnay, France
Hôpitaux Universitaires Paris Sud - Hôpital BicêtreNot Yet Recruiting
Le Kremlin-Bicêtre, France
Groupe Hospitalier Intercommunal Le Raincy-MontfermeilNot Yet Recruiting
Montfermeil, France
Hôpital Bichat - Claude-BernardNot Yet Recruiting
Paris, France
CHU Bordeaux Haut-LevequeNot Yet Recruiting
Pessac, France
Centre Hospitalier Universitaire de Rennes - Hôpital PontchaillouNot Yet Recruiting
Rennes, France
Hôpital FochRecruiting
Suresnes, France
KPPK StudienzentrumRecruiting
Bendorf, Germany
Studienpraxis Berlin-Brandenburg Lennart SchaperRecruiting
Berlin, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum EssenRecruiting
Essen, Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -TRecruiting
Frankfurt, Germany
ME Clinical Respiratory Research HamburgRecruiting
Hamburg, Germany
POIS SachsenRecruiting
Leipzig, Germany
IKF Pneumologie MainzRecruiting
Mainz, Germany
Dedicated Research Site FutureMedsRecruiting
Offenbach, Germany
Galaxy Superspeciality HospitalNot Yet Recruiting
Aurangabad, India
Mahatma Gandhi Mission Medical CollegeNot Yet Recruiting
Aurangabad, India
Medstar Speciality HospitalNot Yet Recruiting
Bangalore, India
All India Institute of Medical SciencesNot Yet Recruiting
Bhubaneswar, India
Aakash Healthcare Private LimitedNot Yet Recruiting
Dwārka, India
Atmaram Child CareNot Yet Recruiting
Kanpur, India
All India Institute of Medical SciencesNot Yet Recruiting
New Delhi, India
Lifepoint Multispeciality HospitalNot Yet Recruiting
Pune, India
All India Institute of Medical SciencesNot Yet Recruiting
Raipur, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical SciencesNot Yet Recruiting
Rohtak, India
Tokyo-Eki Center-building ClinicRecruiting
Chūōku, Japan
Osaka Habikino Medical CenterRecruiting
Habikino, Japan
Aso Iizuka HospitalRecruiting
Iizuka, Japan
Kagoshima University HospitalRecruiting
Kagoshima, Japan
Ishikawa Prefectural Central HospitalRecruiting
Kanazawa, Japan
Kameari Internal Medicine and Respiratory ClinicRecruiting
Katsushika-ku, Japan
Japan Community Healthcare Organization Chukyo HospitalRecruiting
Nagoya, Japan
International University of Health and Welfare Narita HospitalNot Yet Recruiting
Narita, Japan
Okayama University HospitalRecruiting
Okayama, Japan
National Hospital Organization Okayama Medical CenterRecruiting
Okayama, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Kanagawa Cardiovascular and Respiratory CenterRecruiting
Yokohama, Japan
San Peregrino Unidad de InvestigaciónNot Yet Recruiting
Aguascalientes, Mexico
Scientia Investigacion Clinica S.C.Not Yet Recruiting
Chihuahua City, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.Not Yet Recruiting
Durango, Mexico
Instituto Jalisciense de Investigación Clínica Sa de CvNot Yet Recruiting
Guadalajara, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.Not Yet Recruiting
Guadalajara, Mexico
Centro de Desarrollo BiomedicoNot Yet Recruiting
Mérida, Mexico
Kohler & Milstein Research S.A. De C.V.Not Yet Recruiting
Mérida, Mexico
Cicmex Centro de Investigación Clínica de MéxicoNot Yet Recruiting
Morelia, Mexico
Centro de Investigacion Clinica ChapultepecNot Yet Recruiting
Querétaro, Mexico
FAICIC S. de R.L. de C.V.Not Yet Recruiting
Veracruz, Mexico
EB Medical ResearchNot Yet Recruiting
Almere Stad, Netherlands
Amphia Ziekenhuis, locatie Breda MolengrachtNot Yet Recruiting
Breda, Netherlands
Canisius-Wilhelmina ZiekenhuisNot Yet Recruiting
Nijmegen, Netherlands
Franciscus Gasthuis & Vlietland, Locatie GasthuisNot Yet Recruiting
Rotterdam, Netherlands
Gelre ZiekenhuizenNot Yet Recruiting
Zutphen, Netherlands
Isala, locatie ZwolleNot Yet Recruiting
Zwolle, Netherlands
Centrum Medyczne ,,All - Med'' Badania KliniczneRecruiting
Krakow, Poland
Diamond ClinicRecruiting
Krakow, Poland
Alergologia Plus sp. z o.o.Recruiting
Poznan, Poland
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.oRecruiting
Poznan, Poland