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

Last updated: July 3, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

Brenipatide

Clinical Study ID

NCT07219173
27744
2025-522640-41
J2S-MC-GZMR
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Physician-diagnosed asthma who have received a physician-prescribed asthmacontroller 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 2out of 3 visits before randomization.

  • History of 1 severe asthma exacerbation that led to systemic glucocorticoidtreatment in the last 12 months prior to screening visit.

Exclusion

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, includingbut 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 beforescreening visit and up to the randomization visit.

Study Design

Total Participants: 531
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 22, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Consultorios Médicos, Organización del Buen Ayre S.R.L.

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

  • Fundación Respirar

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Consultorios Médicos, Organización del Buen Ayre S.R.L.

    Buenos Aires 3435910, 1425
    Argentina

    Site Not Available

  • Fundación Respirar

    Buenos Aires 3435910, C1426ABP
    Argentina

    Site Not Available

  • IDIM - Instituto de Investigaciones Metabólicas

    Ciudad de Buenos Aires, C1012AAR
    Argentina

    Active - Recruiting

  • Instituto de Asma, Alergia y Enfermedades Respiratorias

    Corrientes, 3400
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, 2152
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, B7600FZO
    Argentina

    Active - Recruiting

  • ABC Instituto de Diagnóstico

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, X5800AEV
    Argentina

    Active - Recruiting

  • Ibamedica

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • NewData Clinical Research - Aracaju

    Aracaju, 49075-000
    Brazil

    Active - Recruiting

  • Private Practice - Dr. Nelson Rosário

    Curitiba, 80810-100
    Brazil

    Active - Recruiting

  • Clinica de Pneumologia

    Goiânia, 74110 030
    Brazil

    Active - Recruiting

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    Marília, 17504-072
    Brazil

    Active - Recruiting

  • Hospital Universitário Onofre Lopes

    Natal, 59012-300
    Brazil

    Active - Recruiting

  • Instituto Atena de Pesquisa Clinica

    Natal, 59020-500
    Brazil

    Active - Recruiting

  • Instituto Atena de Pesquisa Clinica

    Natal 3394023, 59020-500
    Brazil

    Site Not Available

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, 99010-120
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, 14051-140
    Brazil

    Active - Recruiting

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180
    Brazil

    Active - Recruiting

  • Clinica de Alergia Martti Antila

    Sorocaba, 18040-425
    Brazil

    Active - Recruiting

  • Dynamic Drug Advancement

    Ajax, L1S 2J5
    Canada

    Active - Recruiting

  • Heritage Medical Research Clinic

    Calgary, T2N 4Z6
    Canada

    Site Not Available

  • St. Joseph's Healthcare Hamilton

    Hamilton, L8N 4A6
    Canada

    Site Not Available

  • Kelowna Health and Memory Centre

    Kelowna, V1Y 5A8
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal, H4A 3J1
    Canada

    Site Not Available

  • IUCPQ

    Québec, G1V 4G5
    Canada

    Site Not Available

  • Richmond Clinical Trials

    Richmond, V6V 2L1
    Canada

    Active - Recruiting

  • C.I.C. Saint-Laurent

    Saint-Laurent, H4R 3C8
    Canada

    Active - Recruiting

  • Inspiration Research

    Toronto, M5T 3A9
    Canada

    Site Not Available

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, N8X 1T3
    Canada

    Active - Recruiting

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T

    Baotou, 014010
    China

    Active - Recruiting

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, 100020
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014
    China

    Active - Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006
    China

    Active - Recruiting

  • Nanjing Medical University - Nanjing Jiangning Hospital

    Nanjing, 211103
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai, 200080
    China

    Active - Recruiting

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, 518053
    China

    Active - Recruiting

  • The Second Afilliated Hospital of Hebei Medical University

    Shijiazhuang, 050000
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Active - Recruiting

  • The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, 315100
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030
    China

    Active - Recruiting

  • Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence

    Aix-en-Provence, 13100
    France

    Active - Recruiting

  • CHRU de Brest

    Brest, 29609
    France

    Active - Recruiting

  • Centre Hospitalier de Cholet

    Cholet, 49325
    France

    Active - Recruiting

  • Centre Hospitalier de Versailles André Mignot

    Le Chesnay, 78157
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

    Montfermeil, 93370
    France

    Site Not Available

  • Hôpital Bichat - Claude-Bernard

    Paris, 75018
    France

    Active - Recruiting

  • CHU Bordeaux Haut-Leveque

    Pessac, 33600
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, 92150
    France

    Active - Recruiting

  • KPPK Studienzentrum

    Bendorf, 56170
    Germany

    Active - Recruiting

  • Studienpraxis Berlin-Brandenburg Lennart Schaper

    Berlin, 10119
    Germany

    Active - Recruiting

  • Ambulantes Lungenzentrum Essen

    Essen, 45127
    Germany

    Site Not Available

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen

    Essen, 45239
    Germany

    Active - Recruiting

  • IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T

    Frankfurt, 60596
    Germany

    Active - Recruiting

  • ME Clinical Respiratory Research Hamburg

    Hamburg, 22299
    Germany

    Active - Recruiting

  • POIS Sachsen

    Leipzig, 04347
    Germany

    Active - Recruiting

  • IKF Pneumologie Mainz

    Mainz, 55128
    Germany

    Active - Recruiting

  • Dedicated Research Site FutureMeds

    Offenbach, 63065
    Germany

    Active - Recruiting

  • Galaxy Superspeciality Hospital

    Aurangabad, 431001
    India

    Active - Recruiting

  • Mahatma Gandhi Mission Medical College

    Aurangabad, 431003
    India

    Active - Recruiting

  • Galaxy Superspeciality Hospital

    Aurangabad 1278149, 431001
    India

    Site Not Available

  • Medstar Speciality Hospital

    Bangalore, 560092
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    Bhubaneswar, 751019
    India

    Site Not Available

  • Aakash Healthcare Private Limited

    Dwārka, 110075
    India

    Active - Recruiting

  • Atmaram Child Care

    Kanpur, 208011
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    New Delhi, 110029
    India

    Active - Recruiting

  • Lifepoint Multispeciality Hospital

    Pune, 411057
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    Raipur, 492099
    India

    Site Not Available

  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

    Rohtak, 124001
    India

    Active - Recruiting

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027
    Japan

    Active - Recruiting

  • Osaka Habikino Medical Center

    Habikino, 583-8588
    Japan

    Active - Recruiting

  • Aso Iizuka Hospital

    Iizuka, 820-8505
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa, 920-8530
    Japan

    Active - Recruiting

  • Kameari Internal Medicine and Respiratory Clinic

    Katsushika-ku, 125-0061
    Japan

    Active - Recruiting

  • Japan Community Healthcare Organization Chukyo Hospital

    Nagoya, 457-8510
    Japan

    Active - Recruiting

  • International University of Health and Welfare Narita Hospital

    Narita, 286-8520
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama 1854383, 701-1192
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, 236-0051
    Japan

    Active - Recruiting

  • San Peregrino Unidad de Investigación

    Aguascalientes, 20230
    Mexico

    Active - Recruiting

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207
    Mexico

    Active - Recruiting

  • Scientia Investigacion Clinica S.C.

    Chihuahua City 4014338, 31203
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000
    Mexico

    Active - Recruiting

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, 44650
    Mexico

    Site Not Available

  • Instituto Jalisciense de Investigación Clínica Sa de Cv

    Guadalajara, 44100
    Mexico

    Active - Recruiting

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara 4005539, 44650
    Mexico

    Site Not Available

  • Instituto Jalisciense de Investigacion Clinica

    Guadalajara 4005539, 44100
    Mexico

    Site Not Available

  • Cicmex Centro de Investigación Clínica de México

    Morelia, 58020
    Mexico

    Active - Recruiting

  • Centro de Desarrollo Biomedico

    Mérida, 97000
    Mexico

    Site Not Available

  • Kohler & Milstein Research S.A. De C.V.

    Mérida, 97070
    Mexico

    Active - Recruiting

  • Kohler & Milstein Research S.A. De C.V.

    Mérida 3523349, 97070
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica Chapultepec

    Querétaro, 76088
    Mexico

    Site Not Available

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • EB Medical Research

    Almere Stad, 1311 RL
    Netherlands

    Site Not Available

  • Amphia Ziekenhuis, locatie Breda Molengracht

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • Franciscus Gasthuis & Vlietland, Locatie Gasthuis

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • Gelre Ziekenhuizen

    Zutphen, 7207 AE
    Netherlands

    Active - Recruiting

  • Isala, locatie Zwolle

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • Centrum Medyczne ,,All - Med'' Badania Kliniczne

    Krakow, 30-033
    Poland

    Active - Recruiting

  • Diamond Clinic

    Krakow, 31-559
    Poland

    Active - Recruiting

  • Centrum Medyczne ,,All - Med'' Badania Kliniczne

    Krakow 3094802, 30-033
    Poland

    Site Not Available

  • Alergologia Plus sp. z o.o.

    Poznan, 60-693
    Poland

    Active - Recruiting

  • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o

    Poznan, 61-578
    Poland

    Active - Recruiting

  • Alergologia Plus sp. z o.o.

    Poznan 3088171, 60-693
    Poland

    Site Not Available

  • AMR Clinical

    Tempe, Arizona 85281
    United States

    Active - Recruiting

  • NewportNativeMD, Inc.

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • California Medical Research Associates

    Northridge, California 91324
    United States

    Active - Recruiting

  • Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Active - Recruiting

  • Asthma & Allergy Associates - Colorado Springs

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • AMR Clinical

    Doral, Florida 33172-2514
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Avanza Medical Research Center

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • USF Health

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Axis Clinical Trials - Westchester

    Westchester, Illinois 60154
    United States

    Active - Recruiting

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • AMR Clinical

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Equity Medical

    New York, New York 10455
    United States

    Active - Recruiting

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Allergy and Clinical Immunology Associates

    Pittsburgh 5206379, Pennsylvania 6254927 15241
    United States

    Active - Recruiting

  • Vanderbilt Asthma, Sinus and Allergy Program

    Nashville, Tennessee 37203
    United States

    Site Not Available

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