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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

Full criteria on ClinicalTrials.gov

Sites (119)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Consultorios Médicos, Organización del Buen Ayre S.R.L.
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Buenos AiresArgentinaRecruiting
Fundacion Respirar
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Buenos AiresArgentinaRecruiting
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaRecruiting
IDIM - Instituto de Investigaciones Metabólicas
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Ciudad de Buenos AiresArgentinaRecruiting
Instituto de Asma, Alergia y Enfermedades Respiratorias
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CorrientesArgentinaRecruiting
Centro de Investigaciones Clínicas Baigorria
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Granadero BaigorriaArgentinaRecruiting
Instituto de Investigaciones Clinicas Mar del Plata
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Mar del PlataArgentinaRecruiting
Instituto Médico Río Cuarto
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Río CuartoArgentinaRecruiting
ABC Instituto de Diagnóstico
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RosarioArgentinaRecruiting
Ibamedica
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Santa FeArgentinaRecruiting
NewData Clinical Research - Aracaju
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AracajuBrazilRecruiting
Private Practice - Dr. Nelson Rosário
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CuritibaBrazilRecruiting
Clinica de Pneumologia
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GoiâniaBrazilRecruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
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MaríliaBrazilRecruiting
Instituto Atena de Pesquisa Clínica
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NatalBrazilRecruiting
Hospital Universitário Onofre Lopes
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NatalBrazilRecruiting
Instituto Mederi de Pesquisa e Saude
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Passo FundoBrazilRecruiting
Hospital de Clínicas de Ribeirão Preto
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Ribeirão PretoBrazilRecruiting
IBPClin - Instituto Brasil de Pesquisa Clínica
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Rio de JaneiroBrazilRecruiting
Clinica de Alergia Martti Antila
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SorocabaBrazilRecruiting
Dynamic Drug Advancement
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AjaxCanadaRecruiting
St. Joseph's Healthcare Hamilton
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HamiltonCanadaNot yet recruiting
Kelowna Health and Memory Centre
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KelownaCanadaRecruiting
McGill University Health Centre
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MontrealCanadaNot yet recruiting
IUCPQ
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QuébecCanadaRecruiting
Richmond Clinical Trials
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RichmondCanadaRecruiting
C.I.C. Saint-Laurent
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Saint-LaurentCanadaRecruiting
Inspiration Research
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TorontoCanadaRecruiting
Dr. Syed Anees Medicine Professional Corporation
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WindsorCanadaRecruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
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BaotouChinaRecruiting
Beijing Chaoyang Hospital, Capital Medical University
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BeijingChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
Zhejiang Provincial People's Hospital
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HangzhouChinaRecruiting
Jiangxi Provincial People's Hospital
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NanchangChinaRecruiting
Nanjing Medical University - Nanjing Jiangning Hospital
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NanjingChinaRecruiting
Shanghai General Hospital
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ShanghaiChinaRecruiting
The University of Hong Kong-Shenzhen Hospital
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ShenzhenChinaRecruiting
The Second Afilliated Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Tianjin Medical University General Hospital
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TianjinChinaRecruiting
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaRecruiting
KPPK Studienzentrum
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BendorfGermanyRecruiting
Studienpraxis Berlin-Brandenburg Lennart Schaper
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BerlinGermanyRecruiting
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
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EssenGermanyRecruiting
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
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FrankfurtGermanyRecruiting
ME Clinical Respiratory Research Hamburg
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HamburgGermanyRecruiting
POIS Sachsen
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LeipzigGermanyRecruiting
IKF Pneumologie Mainz
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MainzGermanyRecruiting
FutureMeds Offenbach
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OffenbachGermanyRecruiting
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
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Aix-en-ProvenceFranceRecruiting
CHRU de Brest
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BrestFranceRecruiting
Centre Hospitalier de Cholet
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CholetFranceRecruiting
Centre Hospitalier de Versailles André Mignot
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Le ChesnayFranceRecruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
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Le Kremlin-BicêtreFranceRecruiting
Groupe Hospitalier Intercommunal Le Raincy Montfermeil
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MontfermeilFranceRecruiting
Hôpital Bichat - Claude-Bernard
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ParisFranceRecruiting
CHU Bordeaux Haut-Leveque
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
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RennesFranceRecruiting
Hopital Foch
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SuresnesFranceRecruiting
Medstar Speciality Hospital
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BangaloreIndiaRecruiting
All India Institute of Medical Sciences
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BhubaneswarIndiaRecruiting
Galaxy Superspeciality Hospital
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Chhatrapati SambhajinagarIndiaRecruiting
Mahatma Gandhi Mission Medical College
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Chhatrapati SambhajinagarIndiaRecruiting
Aakash Healthcare Private Limited
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DwārkaIndiaRecruiting
Atmaram Child Care
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KanpurIndiaRecruiting
All India Institute of Medical Sciences
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New DelhiIndiaRecruiting
Lifepoint Multispeciality Hospital
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PuneIndiaRecruiting
All India Institute of Medical Sciences
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RaipurIndiaRecruiting
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
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RohtakIndiaRecruiting
Tokyo-Eki Center-building Clinic
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ChūōkuJapanRecruiting
Osaka Habikino Medical Center
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HabikinoJapanRecruiting
Aso Iizuka Hospital
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IizukaJapanRecruiting
Kagoshima University Hospital
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KagoshimaJapanRecruiting
Ishikawa Prefectural Central Hospital
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KanazawaJapanRecruiting
Kameari Internal Medicine and Respiratory Clinic
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Katsushika-kuJapanRecruiting
Japan Community Healthcare Organization Chukyo Hospital
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NagoyaJapanRecruiting
International University of Health and Welfare Narita Hospital
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NaritaJapanRecruiting
Okayama University Hospital
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OkayamaJapanRecruiting
National Hospital Organization Okayama Medical Center
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OkayamaJapanRecruiting
Osaka Metropolitan University Hospital
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OsakaJapanRecruiting
Kanagawa Cardiovascular and Respiratory Center
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YokohamaJapanRecruiting
San Peregrino Unidad de Investigacion
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AguascalientesMexicoRecruiting
Scientia Investigacion Clinica S.C.
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Chihuahua CityMexicoRecruiting
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
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DurangoMexicoRecruiting
Instituto Jalisciense de Investigación Clínica Sa de Cv
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GuadalajaraMexicoRecruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
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GuadalajaraMexicoNot yet recruiting
Köhler & Milstein Research S.A. de C.V.
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MéridaMexicoRecruiting
Centro de Desarrollo Biomedico
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MéridaMexicoNot yet recruiting
Cicmex Centro de Investigación Clínica de México
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MoreliaMexicoRecruiting
Centro de Investigacion Clinica Chapultepec
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QuerétaroMexicoNot yet recruiting
FAICIC S. de R.L. de C.V.
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VeracruzMexicoRecruiting
EB Medical Research
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Almere StadNetherlandsRecruiting
Amphia Ziekenhuis - Locatie Breda Molengracht
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BredaNetherlandsRecruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsNot yet recruiting
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
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RotterdamNetherlandsNot yet recruiting
Gelre Ziekenhuizen
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ZutphenNetherlandsRecruiting
Isala, locatie Zwolle
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ZwolleNetherlandsNot yet recruiting
Centrum Medyczne ,,All - Med'' Badania Kliniczne
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KrakowPolandRecruiting
Diamond Clinic
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KrakowPolandRecruiting
Alergologia Plus sp. z o.o.
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PoznanPolandRecruiting
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
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PoznanPolandRecruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Asthma & Allergy Associates - Colorado Springs
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Colorado SpringsUnited StatesRecruiting
AMR Clinical
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DoralUnited StatesRecruiting
AMR Clinical
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Las VegasUnited StatesRecruiting
Vanderbilt Asthma, Sinus and Allergy Program
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NashvilleUnited StatesNot yet recruiting
NewportNativeMD, Inc.
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Newport BeachUnited StatesRecruiting
Equity Medical
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New YorkUnited StatesRecruiting
California Medical Research Associates
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NorthridgeUnited StatesRecruiting
Renstar Medical Research
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OcalaUnited StatesRecruiting
Allergy & Asthma Specialists, P.S.C.
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OwensboroUnited StatesRecruiting
Avanza Medical Research Center
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PensacolaUnited StatesRecruiting
University of Pittsburgh Medical Center
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PittsburghUnited StatesRecruiting
Allergy and Clinical Immunology Associates
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PittsburghUnited StatesRecruiting
Peninsula Research Associates
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Rolling Hills EstatesUnited StatesRecruiting
USF Health
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TampaUnited StatesRecruiting
AMR Clinical
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TempeUnited StatesRecruiting
Axis Clinical Trials - Westchester
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WestchesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.