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
3 other identifiers
interventional
531
12 countries
121
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Oct 2025
Longer than P75 for phase_2 asthma
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2025
CompletedFirst Posted
Study publicly available on registry
October 21, 2025
CompletedStudy Start
First participant enrolled
October 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 17, 2026
April 1, 2026
2.4 years
October 20, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
To assess the asthma exacerbation rate.
Baseline to Week 52
Secondary Outcomes (6)
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)
Baseline, Week 52
Change from Baseline in Patient Reported Health Outcomes
Baseline, Week 52
Time to First Exacerbation
Baseline to Week 52
Change from Baseline in Weekly Mean Rescue Medication Use
Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Baseline up to Week 52
- +1 more secondary outcomes
Study Arms (3)
Brenipatide Dose 1
EXPERIMENTALBrenipatide administered subcutaneously (SC)
Brenipatide Dose 2
EXPERIMENTALBrenipatide administered SC.
Placebo
PLACEBO COMPARATORPlacebo administered SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
AMR Clinical
Tempe, Arizona, 85281, United States
NewportNativeMD, Inc.
Newport Beach, California, 92663, United States
California Medical Research Associates
Northridge, California, 91324, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Asthma & Allergy Associates - Colorado Springs
Colorado Springs, Colorado, 80907, United States
AMR Clinical
Doral, Florida, 33172-251, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Avanza Medical Research Center
Pensacola, Florida, 32503, United States
USF Health
Tampa, Florida, 33613, United States
Axis Clinical Trials - Westchester
Westchester, Illinois, 60154, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
AMR Clinical
Las Vegas, Nevada, 89119, United States
Equity Medical
New York, New York, 10455, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Vanderbilt Asthma, Sinus and Allergy Program
Nashville, Tennessee, 37203, United States
Consultorios Médicos, Organización del Buen Ayre S.R.L.
Buenos Aires, 1425, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, C1012AAR, Argentina
Instituto de Asma, Alergia y Enfermedades Respiratorias
Corrientes, 3400, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, B7600FZO, Argentina
Instituto Médico Río Cuarto
Río Cuarto, X5800AEV, Argentina
ABC Instituto de Diagnóstico
Rosario, 2000, Argentina
Ibamedica
Santa Fe, 3000, Argentina
NewData Clinical Research - Aracaju
Aracaju, 49075-000, Brazil
Private Practice - Dr. Nelson Rosário
Curitiba, 80810-100, Brazil
Clinica de Pneumologia
Goiânia, 74110 030, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072, Brazil
Hospital Universitário Onofre Lopes
Natal, 59012-300, Brazil
Instituto Atena de Pesquisa Clinica
Natal, 59020-500, Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, 99010-120, Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, 14051-140, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
Clinica de Alergia Martti Antila
Sorocaba, 18040-425, Brazil
Dynamic Drug Advancement
Ajax, L1S 2J5, Canada
Heritage Medical Research Clinic
Calgary, T2N 4Z6, Canada
University Of Alberta Hospital
Edmonton, T6G 1W9, Canada
St. Joseph's Healthcare Hamilton
Hamilton, L8N 4A6, Canada
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8, Canada
McGill University Health Centre
Montreal, H4A 3J1, Canada
IUCPQ
Québec, G1V 4G5, Canada
Richmond Clinical Trials
Richmond, V6V 2L1, Canada
C.I.C. Saint-Laurent
Saint-Laurent, H4R 3C8, Canada
Inspiration Research
Toronto, M5T 3A9, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, N8X 1T3, Canada
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou, 014010, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
Jiangxi Provincial People's Hospital
Nanchang, 330006, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, 211103, China
Shanghai General Hospital
Shanghai, 200080, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053, China
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, 050000, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, 315100, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
Aix-en-Provence, 13100, France
CHRU de Brest
Brest, 29609, France
Centre Hospitalier de Cholet
Cholet, 49325, France
Centre Hospitalier de Versailles André Mignot
Le Chesnay, 78157, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, 93370, France
Hôpital Bichat - Claude-Bernard
Paris, 75018, France
CHU Bordeaux Haut-Leveque
Pessac, 33600, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Hôpital Foch
Suresnes, 92150, France
KPPK Studienzentrum
Bendorf, 56170, Germany
Studienpraxis Berlin-Brandenburg Lennart Schaper
Berlin, 10119, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
Essen, 45239, Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
Frankfurt, 60596, Germany
ME Clinical Respiratory Research Hamburg
Hamburg, 22299, Germany
POIS Sachsen
Leipzig, 04347, Germany
IKF Pneumologie Mainz
Mainz, 55128, Germany
Dedicated Research Site FutureMeds
Offenbach, 63065, Germany
Galaxy Superspeciality Hospital
Aurangabad, 431001, India
Mahatma Gandhi Mission Medical College
Aurangabad, 431003, India
Medstar Speciality Hospital
Bangalore, 560092, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
Aakash Healthcare Private Limited
Dwārka, 110075, India
Atmaram Child Care
Kanpur, 208011, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Lifepoint Multispeciality Hospital
Pune, 411057, India
All India Institute of Medical Sciences
Raipur, 492099, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001, India
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Osaka Habikino Medical Center
Habikino, 583-8588, Japan
Aso Iizuka Hospital
Iizuka, 820-8505, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, 920-8530, Japan
Kameari Internal Medicine and Respiratory Clinic
Katsushika-ku, 125-0061, Japan
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, 457-8510, Japan
International University of Health and Welfare Narita Hospital
Narita, 286-8520, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051, Japan
San Peregrino Unidad de Investigación
Aguascalientes, 20230, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Instituto Jalisciense de Investigación Clínica Sa de Cv
Guadalajara, 44100, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650, Mexico
Centro de Desarrollo Biomedico
Mérida, 97000, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070, Mexico
Cicmex Centro de Investigación Clínica de México
Morelia, 58020, Mexico
Centro de Investigacion Clinica Chapultepec
Querétaro, 76088, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
EB Medical Research
Almere Stad, 1311 RL, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, 4818 CK, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
Rotterdam, 3045 PM, Netherlands
Gelre Ziekenhuizen
Zutphen, 7207 AE, Netherlands
Isala, locatie Zwolle
Zwolle, 8025 AB, Netherlands
Centrum Medyczne ,,All - Med'' Badania Kliniczne
Krakow, 30-033, Poland
Diamond Clinic
Krakow, 31-559, Poland
Alergologia Plus sp. z o.o.
Poznan, 60-693, Poland
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
Poznan, 61-578, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2025
First Posted
October 21, 2025
Study Start
October 22, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement. URL: https://vivli.org/
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.