NCT07219173RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 531 (estimated)
- First submitted
- 20 Oct 2025
- Start date
- 22 Oct 2025
- Primary completion date
- Apr 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Asthma
- NCT number
- NCT07219173
- EudraCT number
- 2025-522640-41
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 531
- From 22 Oct 2025 to the primary completion date, Apr 2028
- 119 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.
Other illness
- 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.
Other
- Participants are excluded from the study if any of the following criteria apply:
- An established diagnosis of occupational asthma
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Consultorios Médicos, Organización del Buen Ayre S.R.L. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| IDIM - Instituto de Investigaciones Metabólicas Coordinator of this site? Confirm its status | Ciudad de Buenos Aires | Argentina | Recruiting |
| Instituto de Asma, Alergia y Enfermedades Respiratorias Coordinator of this site? Confirm its status | Corrientes | Argentina | Recruiting |
| Centro de Investigaciones Clínicas Baigorria Coordinator of this site? Confirm its status | Granadero Baigorria | Argentina | Recruiting |
| Instituto de Investigaciones Clinicas Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| Instituto Médico Río Cuarto Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Recruiting |
| ABC Instituto de Diagnóstico Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Ibamedica Coordinator of this site? Confirm its status | Santa Fe | Argentina | Recruiting |
| NewData Clinical Research - Aracaju Coordinator of this site? Confirm its status | Aracaju | Brazil | Recruiting |
| Private Practice - Dr. Nelson Rosário Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Clinica de Pneumologia Coordinator of this site? Confirm its status | Goiânia | Brazil | Recruiting |
| Centro de Pesquisa Clínica de Marília - CPCLIM Coordinator of this site? Confirm its status | Marília | Brazil | Recruiting |
| Instituto Atena de Pesquisa Clínica Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Hospital Universitário Onofre Lopes Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Instituto Mederi de Pesquisa e Saude Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Recruiting |
| Hospital de Clínicas de Ribeirão Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| IBPClin - Instituto Brasil de Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Clinica de Alergia Martti Antila Coordinator of this site? Confirm its status | Sorocaba | Brazil | Recruiting |
| Dynamic Drug Advancement Coordinator of this site? Confirm its status | Ajax | Canada | Recruiting |
| St. Joseph's Healthcare Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Kelowna Health and Memory Centre Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| IUCPQ Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Richmond Clinical Trials Coordinator of this site? Confirm its status | Richmond | Canada | Recruiting |
| C.I.C. Saint-Laurent Coordinator of this site? Confirm its status | Saint-Laurent | Canada | Recruiting |
| Inspiration Research Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Dr. Syed Anees Medicine Professional Corporation Coordinator of this site? Confirm its status | Windsor | Canada | Recruiting |
| The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T Coordinator of this site? Confirm its status | Baotou | China | Recruiting |
| Beijing Chaoyang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Nanjing Medical University - Nanjing Jiangning Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The University of Hong Kong-Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The Second Afilliated Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| KPPK Studienzentrum Coordinator of this site? Confirm its status | Bendorf | Germany | Recruiting |
| Studienpraxis Berlin-Brandenburg Lennart Schaper Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| ME Clinical Respiratory Research Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| POIS Sachsen Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| IKF Pneumologie Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| FutureMeds Offenbach Coordinator of this site? Confirm its status | Offenbach | Germany | Recruiting |
| Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence Coordinator of this site? Confirm its status | Aix-en-Provence | France | Recruiting |
| CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier de Cholet Coordinator of this site? Confirm its status | Cholet | France | Recruiting |
| Centre Hospitalier de Versailles André Mignot Coordinator of this site? Confirm its status | Le Chesnay | France | Recruiting |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| Groupe Hospitalier Intercommunal Le Raincy Montfermeil Coordinator of this site? Confirm its status | Montfermeil | France | Recruiting |
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Bordeaux Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Medstar Speciality Hospital Coordinator of this site? Confirm its status | Bangalore | India | Recruiting |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Bhubaneswar | India | Recruiting |
| Galaxy Superspeciality Hospital Coordinator of this site? Confirm its status | Chhatrapati Sambhajinagar | India | Recruiting |
| Mahatma Gandhi Mission Medical College Coordinator of this site? Confirm its status | Chhatrapati Sambhajinagar | India | Recruiting |
| Aakash Healthcare Private Limited Coordinator of this site? Confirm its status | Dwārka | India | Recruiting |
| Atmaram Child Care Coordinator of this site? Confirm its status | Kanpur | India | Recruiting |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| Lifepoint Multispeciality Hospital Coordinator of this site? Confirm its status | Pune | India | Recruiting |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Raipur | India | Recruiting |
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Coordinator of this site? Confirm its status | Rohtak | India | Recruiting |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| Osaka Habikino Medical Center Coordinator of this site? Confirm its status | Habikino | Japan | Recruiting |
| Aso Iizuka Hospital Coordinator of this site? Confirm its status | Iizuka | Japan | Recruiting |
| Kagoshima University Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Ishikawa Prefectural Central Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Recruiting |
| Kameari Internal Medicine and Respiratory Clinic Coordinator of this site? Confirm its status | Katsushika-ku | Japan | Recruiting |
| Japan Community Healthcare Organization Chukyo Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| International University of Health and Welfare Narita Hospital Coordinator of this site? Confirm its status | Narita | Japan | Recruiting |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Osaka Metropolitan University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Kanagawa Cardiovascular and Respiratory Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| San Peregrino Unidad de Investigacion Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Recruiting |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Recruiting |
| Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Coordinator of this site? Confirm its status | Durango | Mexico | Recruiting |
| Instituto Jalisciense de Investigación Clínica Sa de Cv Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Clinica de Investigacion en Reumatologia y Obesidad S. C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Not yet recruiting |
| Köhler & Milstein Research S.A. de C.V. Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| Centro de Desarrollo Biomedico Coordinator of this site? Confirm its status | Mérida | Mexico | Not yet recruiting |
| Cicmex Centro de Investigación Clínica de México Coordinator of this site? Confirm its status | Morelia | Mexico | Recruiting |
| Centro de Investigacion Clinica Chapultepec Coordinator of this site? Confirm its status | Querétaro | Mexico | Not yet recruiting |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Recruiting |
| EB Medical Research Coordinator of this site? Confirm its status | Almere Stad | Netherlands | Recruiting |
| Amphia Ziekenhuis - Locatie Breda Molengracht Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Franciscus Gasthuis & Vlietland, Locatie Gasthuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Gelre Ziekenhuizen Coordinator of this site? Confirm its status | Zutphen | Netherlands | Recruiting |
| Isala, locatie Zwolle Coordinator of this site? Confirm its status | Zwolle | Netherlands | Not yet recruiting |
| Centrum Medyczne ,,All - Med'' Badania Kliniczne Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Diamond Clinic Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Alergologia Plus sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Asthma & Allergy Associates - Colorado Springs Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| AMR Clinical Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| AMR Clinical Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Vanderbilt Asthma, Sinus and Allergy Program Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| NewportNativeMD, Inc. Coordinator of this site? Confirm its status | Newport Beach | United States | Recruiting |
| Equity Medical Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| California Medical Research Associates Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| Allergy & Asthma Specialists, P.S.C. Coordinator of this site? Confirm its status | Owensboro | United States | Recruiting |
| Avanza Medical Research Center Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Allergy and Clinical Immunology Associates Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Peninsula Research Associates Coordinator of this site? Confirm its status | Rolling Hills Estates | United States | Recruiting |
| USF Health Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| AMR Clinical Coordinator of this site? Confirm its status | Tempe | United States | Recruiting |
| Axis Clinical Trials - Westchester Coordinator of this site? Confirm its status | Westchester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.