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
Status: Recruiting
Location: See all (122) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
AMR Clinical
RECRUITING
Tempe
California
NewportNativeMD, Inc.
RECRUITING
Newport Beach
California Medical Research Associates
RECRUITING
Northridge
Peninsula Research Associates
RECRUITING
Rolling Hills Estates
Colorado
Asthma & Allergy Associates - Colorado Springs
RECRUITING
Colorado Springs
Florida
AMR Clinical
RECRUITING
Doral
Renstar Medical Research
RECRUITING
Ocala
Avanza Medical Research Center
RECRUITING
Pensacola
USF Health
RECRUITING
Tampa
Illinois
Axis Clinical Trials - Westchester
RECRUITING
Westchester
Kentucky
Allergy & Asthma Specialists, P.S.C.
RECRUITING
Owensboro
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Nevada
AMR Clinical
RECRUITING
Las Vegas
New York
Equity Medical
RECRUITING
New York
Pennsylvania
Allergy and Clinical Immunology Associates
RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Vanderbilt Asthma, Sinus and Allergy Program
NOT_YET_RECRUITING
Nashville
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Buenos Aires
Consultorios Médicos, Organización del Buen Ayre S.R.L.
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Buenos Aires
IDIM - Instituto de Investigaciones Metabólicas
RECRUITING
Ciudad De Buenos Aires
Instituto de Asma, Alergia y Enfermedades Respiratorias
NOT_YET_RECRUITING
Corrientes
Centro de Investigaciones Clínicas Baigorria
RECRUITING
Granadero Baigorria
Instituto de Investigaciones Clínicas Mar del Plata
RECRUITING
Mar Del Plata
Instituto Médico Río Cuarto
RECRUITING
Río Cuarto
ABC Instituto de Diagnóstico
RECRUITING
Rosario
Ibamedica
RECRUITING
Santa Fe
Brazil
NewData Clinical Research - Aracaju
NOT_YET_RECRUITING
Aracaju
Private Practice - Dr. Nelson Rosário
RECRUITING
Curitiba
Clinica de Pneumologia
RECRUITING
Goiânia
Centro de Pesquisa Clínica de Marília - CPCLIM
RECRUITING
Marília
Hospital Universitário Onofre Lopes
NOT_YET_RECRUITING
Natal
Instituto Atena de Pesquisa Clinica
NOT_YET_RECRUITING
Natal
Instituto Méderi de Pesquisa e Saúde
RECRUITING
Passo Fundo
Hospital de Clínicas de Ribeirão Preto
RECRUITING
Ribeirão Preto
IBPClin - Instituto Brasil de Pesquisa Clínica
RECRUITING
Rio De Janeiro
Clinica de Alergia Martti Antila
RECRUITING
Sorocaba
Canada
Dynamic Drug Advancement
RECRUITING
Ajax
Heritage Medical Research Clinic
NOT_YET_RECRUITING
Calgary
University Of Alberta Hospital
SUSPENDED
Edmonton
St. Joseph's Healthcare Hamilton
NOT_YET_RECRUITING
Hamilton
Kelowna Health and Memory Centre
RECRUITING
Kelowna
McGill University Health Centre
NOT_YET_RECRUITING
Montreal
IUCPQ
NOT_YET_RECRUITING
Québec
Richmond Clinical Trials
RECRUITING
Richmond
C.I.C. Saint-Laurent
RECRUITING
Saint-laurent
Inspiration Research
NOT_YET_RECRUITING
Toronto
Dr. Syed Anees Medicine Professional Corporation
RECRUITING
Windsor
China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
RECRUITING
Baotou
Beijing Chaoyang Hospital, Capital Medical University
RECRUITING
Beijing
West China Hospital, Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Nanjing Medical University - Nanjing Jiangning Hospital
RECRUITING
Nanjing
Shanghai General Hospital
RECRUITING
Shanghai
The University of Hong Kong-Shenzhen Hospital
RECRUITING
Shenzhen
The Second Afilliated Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tianjin Medical University General Hospital
RECRUITING
Tianjin
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
France
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
RECRUITING
Aix-en-provence
CHRU de Brest
RECRUITING
Brest
Centre Hospitalier de Cholet
RECRUITING
Cholet
Centre Hospitalier de Versailles André Mignot
NOT_YET_RECRUITING
Le Chesnay
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
NOT_YET_RECRUITING
Montfermeil
Hôpital Bichat - Claude-Bernard
RECRUITING
Paris
CHU Bordeaux Haut-Leveque
NOT_YET_RECRUITING
Pessac
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
NOT_YET_RECRUITING
Rennes
Hôpital Foch
RECRUITING
Suresnes
Germany
KPPK Studienzentrum
RECRUITING
Bendorf
Studienpraxis Berlin-Brandenburg Lennart Schaper
RECRUITING
Berlin
Ambulantes Lungenzentrum Essen
NOT_YET_RECRUITING
Essen
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
RECRUITING
Essen
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
RECRUITING
Frankfurt
ME Clinical Respiratory Research Hamburg
RECRUITING
Hamburg
POIS Sachsen
RECRUITING
Leipzig
IKF Pneumologie Mainz
RECRUITING
Mainz
Dedicated Research Site FutureMeds
RECRUITING
Offenbach
India
Galaxy Superspeciality Hospital
NOT_YET_RECRUITING
Aurangabad
Mahatma Gandhi Mission Medical College
RECRUITING
Aurangabad
Medstar Speciality Hospital
RECRUITING
Bangalore
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Bhubaneswar
Aakash Healthcare Private Limited
RECRUITING
Dwārka
Atmaram Child Care
NOT_YET_RECRUITING
Kanpur
All India Institute of Medical Sciences
NOT_YET_RECRUITING
New Delhi
Lifepoint Multispeciality Hospital
RECRUITING
Pune
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Raipur
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
NOT_YET_RECRUITING
Rohtak
Japan
Tokyo-Eki Center-building Clinic
RECRUITING
Chūōku
Osaka Habikino Medical Center
RECRUITING
Habikino
Aso Iizuka Hospital
RECRUITING
Iizuka
Kagoshima University Hospital
RECRUITING
Kagoshima
Ishikawa Prefectural Central Hospital
RECRUITING
Kanazawa
Kameari Internal Medicine and Respiratory Clinic
RECRUITING
Katsushika-ku
Japan Community Healthcare Organization Chukyo Hospital
RECRUITING
Nagoya
International University of Health and Welfare Narita Hospital
NOT_YET_RECRUITING
Narita
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Okayama University Hospital
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Kanagawa Cardiovascular and Respiratory Center
RECRUITING
Yokohama
Mexico
San Peregrino Unidad de Investigación
RECRUITING
Aguascalientes
Scientia Investigacion Clinica S.C.
RECRUITING
Chihuahua City
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
RECRUITING
Durango
Clinica de Investigacion en Reumatologia y Obesidad S. C.
NOT_YET_RECRUITING
Guadalajara
Instituto Jalisciense de Investigación Clínica Sa de Cv
NOT_YET_RECRUITING
Guadalajara
Centro de Desarrollo Biomedico
NOT_YET_RECRUITING
Mérida
Kohler & Milstein Research S.A. De C.V.
RECRUITING
Mérida
Cicmex Centro de Investigación Clínica de México
RECRUITING
Morelia
Centro de Investigacion Clinica Chapultepec
NOT_YET_RECRUITING
Querétaro
FAICIC S. de R.L. de C.V.
RECRUITING
Veracruz
Netherlands
EB Medical Research
NOT_YET_RECRUITING
Almere Stad
Amphia Ziekenhuis, locatie Breda Molengracht
NOT_YET_RECRUITING
Breda
Canisius-Wilhelmina Ziekenhuis
NOT_YET_RECRUITING
Nijmegen
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
NOT_YET_RECRUITING
Rotterdam
Gelre Ziekenhuizen
NOT_YET_RECRUITING
Zutphen
Isala, locatie Zwolle
NOT_YET_RECRUITING
Zwolle
Poland
Centrum Medyczne ,,All - Med'' Badania Kliniczne
RECRUITING
Krakow
Diamond Clinic
RECRUITING
Krakow
Alergologia Plus sp. z o.o.
RECRUITING
Poznan
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
RECRUITING
Poznan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2028-06
Participants
Target number of participants: 531
Treatments
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneously (SC)
Experimental: Brenipatide Dose 2
Brenipatide administered SC.
Placebo_comparator: Placebo
Placebo administered SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company