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Recruiting Phase 2 NCT07219173

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Phase 2 – studying effectiveness and dosage
Conditions: Asthma

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Brenipatide
DRUG
Brenipatide
DRUG
Placebo
DRUG
Locations 121
Argentina (10)
Consultorios Médicos, Organización del Buen Ayre S.R.L.
Buenos Aires
NOT_YET_RECRUITING
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
NOT_YET_RECRUITING
Fundación Respirar
Buenos Aires
NOT_YET_RECRUITING
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires
NOT_YET_RECRUITING
Instituto de Asma, Alergia y Enfermedades Respiratorias
Corrientes
NOT_YET_RECRUITING
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria
NOT_YET_RECRUITING
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata
NOT_YET_RECRUITING
Instituto Médico Río Cuarto
Río Cuarto
NOT_YET_RECRUITING
ABC Instituto de Diagnóstico
Rosario
NOT_YET_RECRUITING
Ibamedica
Santa Fe
NOT_YET_RECRUITING
Brazil (10)
NewData Clinical Research - Aracaju
Aracaju
NOT_YET_RECRUITING
Private Practice - Dr. Nelson Rosário
Curitiba
NOT_YET_RECRUITING
Clinica de Pneumologia
Goiânia
NOT_YET_RECRUITING
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília
NOT_YET_RECRUITING
Hospital Universitário Onofre Lopes
Natal
NOT_YET_RECRUITING
Instituto Atena de Pesquisa Clinica
Natal
NOT_YET_RECRUITING
Instituto Méderi de Pesquisa e Saúde
Passo Fundo
NOT_YET_RECRUITING
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto
NOT_YET_RECRUITING
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro
NOT_YET_RECRUITING
Clinica de Alergia Martti Antila
Sorocaba
NOT_YET_RECRUITING
Canada (11)
Dynamic Drug Advancement
Ajax
Heritage Medical Research Clinic
Calgary
NOT_YET_RECRUITING
University Of Alberta Hospital
Edmonton
SUSPENDED
St. Joseph's Healthcare Hamilton
Hamilton
NOT_YET_RECRUITING
Kelowna Health and Memory Centre
Kelowna
McGill University Health Centre
Montreal
NOT_YET_RECRUITING
IUCPQ
Québec
NOT_YET_RECRUITING
Richmond Clinical Trials
Richmond
C.I.C. Saint-Laurent
Saint-Laurent
Inspiration Research
Toronto
NOT_YET_RECRUITING
Dr. Syed Anees Medicine Professional Corporation
Windsor
China (13)
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou
Beijing Chaoyang Hospital, Capital Medical University
Beijing
West China Hospital, Sichuan University
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Zhejiang Provincial People's Hospital
Hangzhou
Jiangxi Provincial People's Hospital
Nanchang
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing
Shanghai General Hospital
Shanghai
The University of Hong Kong-Shenzhen Hospital
Shenzhen
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang
Tianjin Medical University General Hospital
Tianjin
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan
France (10)
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
Aix-en-Provence
CHRU de Brest
Brest
Centre Hospitalier de Cholet
Cholet
Centre Hospitalier de Versailles André Mignot
Le Chesnay
NOT_YET_RECRUITING
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre
NOT_YET_RECRUITING
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil
NOT_YET_RECRUITING
Hôpital Bichat - Claude-Bernard
Paris
NOT_YET_RECRUITING
CHU Bordeaux Haut-Leveque
Pessac
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes
NOT_YET_RECRUITING
Hôpital Foch
Suresnes
Germany (8)
KPPK Studienzentrum
Bendorf
Studienpraxis Berlin-Brandenburg Lennart Schaper
Berlin
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
Essen
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
Frankfurt
ME Clinical Respiratory Research Hamburg
Hamburg
POIS Sachsen
Leipzig
IKF Pneumologie Mainz
Mainz
Dedicated Research Site FutureMeds
Offenbach
India (10)
Galaxy Superspeciality Hospital
Aurangabad
NOT_YET_RECRUITING
Mahatma Gandhi Mission Medical College
Aurangabad
NOT_YET_RECRUITING
Medstar Speciality Hospital
Bangalore
NOT_YET_RECRUITING
All India Institute of Medical Sciences
Bhubaneswar
NOT_YET_RECRUITING
Aakash Healthcare Private Limited
Dwārka
NOT_YET_RECRUITING
Atmaram Child Care
Kanpur
NOT_YET_RECRUITING
All India Institute of Medical Sciences
New Delhi
NOT_YET_RECRUITING
Lifepoint Multispeciality Hospital
Pune
NOT_YET_RECRUITING
All India Institute of Medical Sciences
Raipur
NOT_YET_RECRUITING
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak
NOT_YET_RECRUITING
Japan (12)
Tokyo-Eki Center-building Clinic
Chūōku
Osaka Habikino Medical Center
Habikino
Aso Iizuka Hospital
Iizuka
Kagoshima University Hospital
Kagoshima
Ishikawa Prefectural Central Hospital
Kanazawa
Kameari Internal Medicine and Respiratory Clinic
Katsushika-ku
Japan Community Healthcare Organization Chukyo Hospital
Nagoya
International University of Health and Welfare Narita Hospital
Narita
NOT_YET_RECRUITING
Okayama University Hospital
Okayama
National Hospital Organization Okayama Medical Center
Okayama
Osaka Metropolitan University Hospital
Osaka
Kanagawa Cardiovascular and Respiratory Center
Yokohama
Mexico (10)
San Peregrino Unidad de Investigación
Aguascalientes
NOT_YET_RECRUITING
Scientia Investigacion Clinica S.C.
Chihuahua City
NOT_YET_RECRUITING
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango
NOT_YET_RECRUITING
Instituto Jalisciense de Investigación Clínica Sa de Cv
Guadalajara
NOT_YET_RECRUITING
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara
NOT_YET_RECRUITING
Centro de Desarrollo Biomedico
Mérida
NOT_YET_RECRUITING
Kohler & Milstein Research S.A. De C.V.
Mérida
NOT_YET_RECRUITING
Cicmex Centro de Investigación Clínica de México
Morelia
NOT_YET_RECRUITING
Centro de Investigacion Clinica Chapultepec
Querétaro
NOT_YET_RECRUITING
FAICIC S. de R.L. de C.V.
Veracruz
NOT_YET_RECRUITING
Netherlands (6)
EB Medical Research
Almere Stad
NOT_YET_RECRUITING
Amphia Ziekenhuis, locatie Breda Molengracht
Breda
NOT_YET_RECRUITING
Canisius-Wilhelmina Ziekenhuis
Nijmegen
NOT_YET_RECRUITING
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
Rotterdam
NOT_YET_RECRUITING
Gelre Ziekenhuizen
Zutphen
NOT_YET_RECRUITING
Isala, locatie Zwolle
Zwolle
NOT_YET_RECRUITING
Poland (4)
Centrum Medyczne ,,All - Med'' Badania Kliniczne
Krakow
Diamond Clinic
Krakow
Alergologia Plus sp. z o.o.
Poznan
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
Poznan
United States (17)
Brigham and Women's Hospital
Boston , Massachusetts
Asthma & Allergy Associates - Colorado Springs
Colorado Springs , Colorado
AMR Clinical
Doral , Florida
AMR Clinical
Las Vegas , Nevada
Vanderbilt Asthma, Sinus and Allergy Program
Nashville , Tennessee
NOT_YET_RECRUITING
Equity Medical
New York , New York
NewportNativeMD, Inc.
Newport Beach , California
California Medical Research Associates
Northridge , California
Renstar Medical Research
Ocala , Florida
Allergy & Asthma Specialists, P.S.C.
Owensboro , Kentucky
Avanza Medical Research Center
Pensacola , Florida
University of Pittsburgh Medical Center
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Allergy and Clinical Immunology Associates
Pittsburgh , Pennsylvania
Peninsula Research Associates
Rolling Hills Estates , California
USF Health
Tampa , Florida
AMR Clinical
Tempe , Arizona
Axis Clinical Trials - Westchester
Westchester , Illinois
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
22.10.2025
Completion date
01.06.2028
Registry ID
NCT07219173
Source
clinicaltrials.gov
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