A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
NCT ID: NCT07219173
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
531 participants
INTERVENTIONAL
2025-10-22
2028-06-30
Brief Summary
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Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brenipatide Dose 1
Brenipatide administered subcutaneously (SC)
Brenipatide
Administered SC
Brenipatide Dose 2
Brenipatide administered SC.
Brenipatide
Administered SC
Placebo
Placebo administered SC.
Placebo
Administered SC
Interventions
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Brenipatide
Administered SC
Brenipatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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AMR Clinical
Tempe, Arizona, United States
NewportNativeMD, Inc.
Newport Beach, California, United States
California Medical Research Associates
Northridge, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Asthma & Allergy Associates - Colorado Springs
Colorado Springs, Colorado, United States
AMR Clinical
Doral, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
USF Health
Tampa, Florida, United States
Axis Clinical Trials - Westchester
Westchester, Illinois, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
AMR Clinical
Las Vegas, Nevada, United States
Equity Medical
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Vanderbilt Asthma, Sinus and Allergy Program
Nashville, Tennessee, United States
Consultorios Médicos, Organización del Buen Ayre S.R.L.
Buenos Aires, , Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, , Argentina
Instituto de Asma, Alergia y Enfermedades Respiratorias
Corrientes, , Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, , Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, , Argentina
Instituto Médico Río Cuarto
Río Cuarto, , Argentina
ABC Instituto de Diagnóstico
Rosario, , Argentina
Ibamedica
Santa Fe, , Argentina
NewData Clinical Research - Aracaju
Aracaju, , Brazil
Private Practice - Dr. Nelson Rosário
Curitiba, , Brazil
Clinica de Pneumologia
Goiânia, , Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, , Brazil
Hospital Universitário Onofre Lopes
Natal, , Brazil
Instituto Atena de Pesquisa Clinica
Natal, , Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, , Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, , Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
Clinica de Alergia Martti Antila
Sorocaba, , Brazil
Dynamic Drug Advancement
Ajax, , Canada
Heritage Medical Research Clinic
Calgary, , Canada
University Of Alberta Hospital
Edmonton, , Canada
St. Joseph's Healthcare Hamilton
Hamilton, , Canada
Kelowna Health and Memory Centre
Kelowna, , Canada
McGill University Health Centre
Montreal, , Canada
IUCPQ
Québec, , Canada
Richmond Clinical Trials
Richmond, , Canada
C.I.C. Saint-Laurent
Saint-Laurent, , Canada
Inspiration Research
Toronto, , Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, , Canada
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou, , China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, , China
Shanghai General Hospital
Shanghai, , China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, , China
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, , China
Tianjin Medical University General Hospital
Tianjin, , China
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, , China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
Aix-en-Provence, , France
CHRU de Brest
Brest, , France
Centre Hospitalier de Cholet
Cholet, , France
Centre Hospitalier de Versailles André Mignot
Le Chesnay, , France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, , France
Hôpital Bichat - Claude-Bernard
Paris, , France
CHU Bordeaux Haut-Leveque
Pessac, , France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, , France
Hôpital Foch
Suresnes, , France
KPPK Studienzentrum
Bendorf, , Germany
Studienpraxis Berlin-Brandenburg Lennart Schaper
Berlin, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
Essen, , Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
Frankfurt, , Germany
ME Clinical Respiratory Research Hamburg
Hamburg, , Germany
POIS Sachsen
Leipzig, , Germany
IKF Pneumologie Mainz
Mainz, , Germany
Dedicated Research Site FutureMeds
Offenbach, , Germany
Galaxy Superspeciality Hospital
Aurangabad, , India
Mahatma Gandhi Mission Medical College
Aurangabad, , India
Medstar Speciality Hospital
Bangalore, , India
All India Institute of Medical Sciences
Bhubaneswar, , India
Aakash Healthcare Private Limited
Dwārka, , India
Atmaram Child Care
Kanpur, , India
All India Institute of Medical Sciences
New Delhi, , India
Lifepoint Multispeciality Hospital
Pune, , India
All India Institute of Medical Sciences
Raipur, , India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, , India
Tokyo-Eki Center-building Clinic
Chūōku, , Japan
Osaka Habikino Medical Center
Habikino, , Japan
Aso Iizuka Hospital
Iizuka, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Ishikawa Prefectural Central Hospital
Kanazawa, , Japan
Kameari Internal Medicine and Respiratory Clinic
Katsushika-ku, , Japan
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, , Japan
San Peregrino Unidad de Investigación
Aguascalientes, , Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Instituto Jalisciense de Investigación Clínica Sa de Cv
Guadalajara, , Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, , Mexico
Centro de Desarrollo Biomedico
Mérida, , Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, , Mexico
Cicmex Centro de Investigación Clínica de México
Morelia, , Mexico
Centro de Investigacion Clinica Chapultepec
Querétaro, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
EB Medical Research
Almere Stad, , Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
Rotterdam, , Netherlands
Gelre Ziekenhuizen
Zutphen, , Netherlands
Isala, locatie Zwolle
Zwolle, , Netherlands
Centrum Medyczne ,,All - Med'' Badania Kliniczne
Krakow, , Poland
Diamond Clinic
Krakow, , Poland
Alergologia Plus sp. z o.o.
Poznan, , Poland
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
Poznan, , Poland
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
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Role: CONTACT
Facility Contacts
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Other Identifiers
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2025-522640-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
J2S-MC-GZMR
Identifier Type: OTHER
Identifier Source: secondary_id
27744
Identifier Type: -
Identifier Source: org_study_id
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