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

June 2, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

531

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundación Respirar
        • Principal Investigator:
          • Pablo Doreski
        • Contact:
          • Phone Number: +549115 800 5058
      • Buenos Aires, Argentina, C1056ABI
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Contact:
          • Phone Number: 08003450697
        • Principal Investigator:
          • Gonzalo Saenz
      • Buenos Aires, Argentina, 1425
        • Recruiting
        • Consultorios Médicos, Organización del Buen Ayre S.R.L.
        • Contact:
          • Phone Number: +541168893232
        • Principal Investigator:
          • Silvina Riva
      • Ciudad de Buenos Aires, Argentina, C1012AAR
        • Recruiting
        • IDIM - Instituto de Investigaciones Metabólicas
        • Contact:
          • Phone Number: 541154143028
        • Principal Investigator:
          • Ricardo del Olmo Sansone
      • Corrientes, Argentina, 3400
        • Not yet recruiting
        • Instituto de Asma, Alergia y Enfermedades Respiratorias
        • Contact:
          • Phone Number: +5493794391031
        • Principal Investigator:
          • Alejandro Berardi
      • Granadero Baigorria, Argentina, 2152
        • Recruiting
        • Centro de Investigaciones Clinicas Baigorria
        • Principal Investigator:
          • Rodolfo Navarrete
        • Contact:
          • Phone Number: +5493416008195
      • Mar del Plata, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clinicas Mar del Plata
        • Contact:
          • Phone Number: +54 9 2234 24-0652
        • Principal Investigator:
          • Pablo Martinez Monferran
      • Rosario, Argentina, 2000
        • Recruiting
        • ABC Instituto de Diagnóstico
        • Principal Investigator:
          • Adriana Marcipar
        • Contact:
          • Phone Number: 54 341 397379
      • Río Cuarto, Argentina, X5800AEV
        • Recruiting
        • Instituto Médico Río Cuarto
        • Contact:
          • Phone Number: 541131077237
        • Principal Investigator:
          • Carolina Cappelletti
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Ibamedica
        • Principal Investigator:
          • Martin Maillo
        • Contact:
          • Phone Number: 543424564943
  • Brazil
      • Aracaju, Brazil, 49075-000
        • Not yet recruiting
        • NewData Clinical Research - Aracaju
        • Principal Investigator:
          • Ivan Mendes
      • Curitiba, Brazil, 80810-100
        • Recruiting
        • Private Practice - Dr. Nelson Rosário
        • Contact:
          • Phone Number: 5541 3208 6500
        • Principal Investigator:
          • Nelson Rosario Filho
      • Goiânia, Brazil, 74110 030
        • Recruiting
        • Clinica de Pneumologia
        • Principal Investigator:
          • Marcelo Rabahi
      • Marília, Brazil, 17504-072
        • Recruiting
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Principal Investigator:
          • Bruno de Oliveira
      • Natal, Brazil, 59020-500
        • Not yet recruiting
        • Instituto Atena de Pesquisa Clinica
        • Principal Investigator:
          • Hugo Paiva
      • Natal, Brazil, 59012-300
        • Not yet recruiting
        • Hospital Universitário Onofre Lopes
        • Principal Investigator:
          • Suzianne Pinto
      • Passo Fundo, Brazil, 99010-120
        • Recruiting
        • Instituto Mederi de Pesquisa e Saude
        • Contact:
          • Phone Number: 55 54 3581 1831
        • Principal Investigator:
          • Tiago Simon
      • Ribeirão Preto, Brazil, 14051-140
        • Recruiting
        • Hospital de Clínicas de Ribeirão Preto
        • Principal Investigator:
          • MARIA EDUARDA ZANETTI
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • IBPClin - Instituto Brasil de Pesquisa Clínica
        • Contact:
          • Phone Number: +552125277979
        • Principal Investigator:
          • Priscila Wolff
      • Sorocaba, Brazil, 18040-425
        • Recruiting
        • Clinica de Alergia Martti Antila
        • Contact:
          • Phone Number: 551535194909
        • Principal Investigator:
          • MARTTI ANTILA
  • Canada
      • Ajax, Canada, L1S 2J5
        • Recruiting
        • Dynamic Drug Advancement
        • Principal Investigator:
          • George Philteos
        • Contact:
          • Phone Number: 3658859086
      • Calgary, Canada, T2N 4Z6
        • Not yet recruiting
        • Heritage Medical Research Clinic
        • Principal Investigator:
          • Danica Brister
      • Edmonton, Canada, T6G 1W9
        • Suspended
        • University of Alberta Hospital
      • Hamilton, Canada, L8N 4A6
        • Not yet recruiting
        • St. Joseph's Healthcare Hamilton
        • Principal Investigator:
          • Parameswaran Nair
      • Kelowna, Canada, V1Y 5A8
        • Recruiting
        • Kelowna Health and Memory Centre
        • Principal Investigator:
          • Colleen Maytham
      • Montreal, Canada, H4A 3J1
        • Not yet recruiting
        • McGill University Health Centre
        • Principal Investigator:
          • Nermin Diab
      • Québec, Canada, G1V 4G5
        • Not yet recruiting
        • IUCPQ
        • Principal Investigator:
          • Andreanne Cote
      • Richmond, Canada, V6V 2L1
        • Recruiting
        • Richmond Clinical Trials
        • Contact:
          • Phone Number: 604-373-4954
        • Principal Investigator:
          • Alexandra Lucas
      • Saint-Laurent, Canada, H4R 3C8
        • Recruiting
        • C.I.C. Saint-Laurent
        • Principal Investigator:
          • Isabel Coman
      • Toronto, Canada, M5T 3A9
        • Not yet recruiting
        • Inspiration Research
        • Principal Investigator:
          • Kenneth Chapman
        • Contact:
          • Phone Number: 4169449602
      • Windsor, Canada, N8X 1T3
        • Recruiting
        • Dr. Syed Anees Medicine Professional Corporation
        • Principal Investigator:
          • Syed Anees
        • Contact:
          • Phone Number: (519) 252-4448
  • China
      • Baotou, China, 014010
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
        • Principal Investigator:
          • Yao Ma
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Principal Investigator:
          • Kewu Huang
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Gang Wang
      • Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Phone Number: 13101363078
        • Principal Investigator:
          • Shuliang Guo
      • Hangzhou, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Principal Investigator:
          • Yilan Sun
      • Nanchang, China, 330006
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Phone Number: 13576030963
        • Principal Investigator:
          • Xiya Wu
      • Nanjing, China, 211103
        • Recruiting
        • Nanjing Medical University - Nanjing Jiangning Hospital
        • Principal Investigator:
          • Xiuwei Zhang
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Principal Investigator:
          • Min Zhang
      • Shenzhen, China, 518053
        • Recruiting
        • The University of Hong Kong-Shenzhen Hospital
        • Principal Investigator:
          • Lei Rong
      • Shijiazhuang, China, 050000
        • Recruiting
        • The Second Afilliated Hospital of Hebei Medical University
        • Principal Investigator:
          • zhigang cai
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Phone Number: 13132088076
        • Principal Investigator:
          • Jie Cao
      • Wenzhou, China, 315100
        • Recruiting
        • The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Liqin Wu
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
        • Principal Investigator:
          • Min Xie
  • France
      • Aix-en-Provence, France, 13100
        • Recruiting
        • Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
        • Principal Investigator:
          • Youssef TRIGUI
      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest
        • Principal Investigator:
          • Raphael Le Mao
      • Cholet, France, 49325
        • Recruiting
        • Centre Hospitalier de Cholet
        • Principal Investigator:
          • Pauline BEURRIER
      • Le Chesnay, France, 78157
        • Not yet recruiting
        • Centre Hospitalier de Versailles André Mignot
        • Principal Investigator:
          • Gilles Garcia
        • Contact:
          • Phone Number: 0661073507
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
        • Principal Investigator:
          • Antoine Beurnier
      • Montfermeil, France, 93370
        • Not yet recruiting
        • Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
        • Principal Investigator:
          • Cyril Maurer
        • Contact:
          • Phone Number: 0141708160
      • Paris, France, 75018
        • Recruiting
        • Hôpital Bichat - Claude-Bernard
        • Principal Investigator:
          • Camille Taillé
        • Contact:
          • Phone Number: 0684629275
      • Pessac, France, 33600
        • Not yet recruiting
        • CHU Bordeaux Haut-Levêque
        • Contact:
          • Phone Number: +330557656039
        • Principal Investigator:
          • Pierre-Olivier Girodet
      • Rennes, France, 35033
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
        • Principal Investigator:
          • Chantal Belleguic
      • Suresnes, France, 92150
        • Recruiting
        • Hopital Foch
        • Principal Investigator:
          • Céline Goyard
  • Germany
      • Bendorf, Germany, 56170
        • Recruiting
        • KPPK Studienzentrum
        • Principal Investigator:
          • Olaf Schmidt
        • Contact:
          • Phone Number: 004926228983390
      • Berlin, Germany, 10119
        • Recruiting
        • Studienpraxis Berlin-Brandenburg Lennart Schaper
        • Principal Investigator:
          • Lennart Schaper
        • Contact:
          • Phone Number: +493044048226
      • Essen, Germany, 45239
        • Recruiting
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
        • Contact:
          • Phone Number: 00492014334503
        • Principal Investigator:
          • Sivagurunathan Sutharsan
      • Essen, Germany, 45127
        • Not yet recruiting
        • Ambulantes Lungenzentrum Essen
        • Contact:
          • Phone Number: 00492014334503
        • Principal Investigator:
          • Sivagurunathan Sutharsan
      • Frankfurt, Germany, 60596
        • Recruiting
        • IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
        • Principal Investigator:
          • Andreas Eich
        • Contact:
          • Phone Number: 4969695972580
      • Hamburg, Germany, 22299
        • Recruiting
        • ME Clinical Respiratory Research Hamburg
        • Principal Investigator:
          • Martin Ehlers
        • Contact:
          • Phone Number: 0049 40 46095194
      • Leipzig, Germany, 04347
        • Recruiting
        • POIS Sachsen
        • Contact:
          • Phone Number: 034160050650
        • Principal Investigator:
          • Juliana Brode
      • Mainz, Germany, 55128
        • Recruiting
        • IKF Pneumologie Mainz
        • Principal Investigator:
          • Stephanie Korn
      • Offenbach, Germany, 63065
        • Recruiting
        • Dedicated Research Site FutureMeds
        • Principal Investigator:
          • Christel Contzen
        • Contact:
          • Phone Number: 0049 69 247433849
  • India
      • Aurangabad, India, 431001
        • Not yet recruiting
        • Galaxy Superspeciality Hospital
        • Principal Investigator:
          • Shreehas Bardapurkar
      • Aurangabad, India, 431003
        • Recruiting
        • Mahatma Gandhi Mission Medical College
        • Contact:
          • Phone Number: +91-8390628800
        • Principal Investigator:
          • Deshmukh Mohd
      • Bangalore, India, 560092
        • Recruiting
        • Medstar Speciality Hospital
        • Principal Investigator:
          • Hirennappa B. Udnur
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Mahismita Patro
      • Dwārka, India, 110075
        • Recruiting
        • Aakash Healthcare Private Limited
        • Principal Investigator:
          • Akshay Budhraja
        • Contact:
          • Phone Number: 09910425552
      • Kanpur, India, 208011
        • Not yet recruiting
        • Atmaram Child Care
        • Principal Investigator:
          • Arjun Bhatnagar
      • New Delhi, India, 110029
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Saurabh Mittal
      • Pune, India, 411057
        • Recruiting
        • Lifepoint Multispeciality Hospital
        • Contact:
          • Phone Number: +91-9028560535
        • Principal Investigator:
          • Rajkumar Nikalje
      • Raipur, India, 492099
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Dibakar Sahu
      • Rohtak, India, 124001
        • Not yet recruiting
        • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
        • Principal Investigator:
          • Aman Ahuja
  • Japan
      • Chūōku, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Arihiro Kiyosue
      • Habikino, Japan, 583-8588
        • Recruiting
        • Osaka Habikino Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Osamu Matsuno
      • Iizuka, Japan, 820-8505
        • Recruiting
        • Aso Iizuka Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazunori Tobino
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takahiro Matsuyama
      • Kanazawa, Japan, 920-8530
        • Recruiting
        • Ishikawa Prefectural Central Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshihiro Takeda
      • Katsushika-ku, Japan, 125-0061
        • Recruiting
        • Kameari Internal Medicine and Respiratory Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • HARUHIKO YANAGISAWA
      • Nagoya, Japan, 457-8510
        • Recruiting
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shuichi Asano
      • Narita, Japan, 286-8520
        • Not yet recruiting
        • International University of Health and Welfare Narita Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasuo To
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Nobuaki Miyahara
      • Okayama, Japan, 701-1192
        • Recruiting
        • National Hospital Organization Okayama Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Keiichi Fujiwara
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazuhisa Asai
      • Yokohama, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shigeru Komatsu
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Recruiting
        • San Peregrino Unidad de Investigación
        • Contact:
          • Phone Number: 4491114337
        • Principal Investigator:
          • MELISSA ONOFRE BORJA
      • Chihuahua City, Mexico, 31207
        • Recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Ilse Loya Barriga
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
        • Principal Investigator:
          • Edwin Daniel MALDONADO DOMINGUEZ
      • Guadalajara, Mexico, 44650
        • Not yet recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
        • Contact:
          • Phone Number: 3331200700
        • Principal Investigator:
          • Bertha Nachelly Gonzalez
      • Guadalajara, Mexico, 44100
        • Not yet recruiting
        • Instituto Jalisciense de Investigación Clínica Sa de Cv
        • Principal Investigator:
          • Daniel Salazar Quiroz
      • Morelia, Mexico, 58020
        • Recruiting
        • Cicmex Centro de Investigación Clínica de México
        • Principal Investigator:
          • Marco Tafolla Manzo
      • Mérida, Mexico, 97000
        • Not yet recruiting
        • Centro de Desarrollo Biomedico
        • Contact:
          • Phone Number: 9992855178
        • Principal Investigator:
          • Raul Bracamonte Peraza
      • Mérida, Mexico, 97070
        • Recruiting
        • Köhler & Milstein Research S.A. de C.V.
        • Contact:
          • Phone Number: 529999204004
        • Principal Investigator:
          • Carlos Colonia Cano
      • Querétaro, Mexico, 76088
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • PEDRO DANIEL ALVARADO
      • Veracruz, Mexico, 91900
        • Recruiting
        • FAICIC S. de R.L. de C.V.
        • Contact:
          • Phone Number: 2299327808
        • Principal Investigator:
          • Luis Domínguez Sansores
  • Netherlands
      • Almere Stad, Netherlands, 1311 RL
        • Not yet recruiting
        • EB Medical Research
        • Principal Investigator:
          • Mazin Alhakim
        • Contact:
          • Phone Number: 0031365468346
      • Breda, Netherlands, 4818 CK
        • Not yet recruiting
        • Amphia Ziekenhuis, locatie Breda Molengracht
        • Contact:
          • Phone Number: 0031-76-5952383
        • Principal Investigator:
          • Simone van der Sar - Brugge
      • Nijmegen, Netherlands, 6532 SZ
        • Not yet recruiting
        • Canisius-Wilhelmina Ziekenhuis
        • Contact:
          • Phone Number: 0243658755
        • Principal Investigator:
          • Juergen Hoelters
      • Rotterdam, Netherlands, 3045 PM
        • Not yet recruiting
        • Franciscus Gasthuis & Vlietland, Locatie Gasthuis
        • Principal Investigator:
          • Gert-Jan Braunstahl
        • Contact:
          • Phone Number: 0104616619
      • Zutphen, Netherlands, 7207 AE
        • Not yet recruiting
        • Gelre Ziekenhuizen
        • Principal Investigator:
          • Martijn Goosens
        • Contact:
          • Phone Number: +31575592322
      • Zwolle, Netherlands, 8025 AB
        • Not yet recruiting
        • Isala, locatie Zwolle
        • Contact:
          • Phone Number: 0031 88 6243254
        • Principal Investigator:
          • Kornelis Patberg
  • Poland
      • Krakow, Poland, 31-559
        • Recruiting
        • Diamond Clinic
        • Principal Investigator:
          • Barbara Rewerska
        • Contact:
          • Phone Number: + 48 696 049 029
      • Krakow, Poland, 30-033
        • Recruiting
        • Centrum Medyczne ,,All - Med'' Badania Kliniczne
        • Principal Investigator:
          • Grazyna Pulka
        • Contact:
          • Phone Number: 48124223271
      • Poznan, Poland, 60-693
        • Recruiting
        • Alergologia Plus sp. z o.o.
        • Principal Investigator:
          • Michal Springer
        • Contact:
          • Phone Number: +48616562160
      • Poznan, Poland, 61-578
        • Recruiting
        • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
        • Principal Investigator:
          • Danuta Madra-Rogacka
        • Contact:
          • Phone Number: +48 601 751 713
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Recruiting
        • AMR Clinical
        • Contact:
          • Phone Number: 602-910-3343
        • Principal Investigator:
          • William Reedy
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • NewportNativeMD, Inc.
        • Contact:
          • Phone Number: 949-791-8599
        • Principal Investigator:
          • Ryan Klein
      • Northridge, California, United States, 91324
        • Recruiting
        • California Medical Research Associates
        • Principal Investigator:
          • Sanjay Vadgama
      • Rolling Hills Estates, California, United States, 90274
        • Recruiting
        • Peninsula Research Associates
        • Contact:
          • Phone Number: 310-265-1623
        • Principal Investigator:
          • Lawrence Sher
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Asthma & Allergy Associates - Colorado Springs
        • Principal Investigator:
          • Luke Webb
    • Florida
      • Doral, Florida, United States, 33172-2514
        • Recruiting
        • AMR Clinical
        • Principal Investigator:
          • Abid Chaudhry
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
        • Contact:
          • Phone Number: 352-629-5800
        • Principal Investigator:
          • Raj Karunakara
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Avanza Medical Research Center
        • Contact:
          • Phone Number: 850-477-7900
        • Principal Investigator:
          • Linda McCafferty
      • Tampa, Florida, United States, 33613
        • Recruiting
        • USF Health
        • Contact:
          • Phone Number: 813-631-4024
        • Principal Investigator:
          • Thomas Casale
    • Illinois
      • Westchester, Illinois, United States, 60154
        • Recruiting
        • Axis Clinical Trials - Westchester
        • Principal Investigator:
          • Mohammad Ghani
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Recruiting
        • Allergy & Asthma Specialists, P.S.C.
        • Principal Investigator:
          • Lee Clore
        • Contact:
          • Phone Number: 270-684-6144
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Dinah Foer
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • AMR Clinical
        • Principal Investigator:
          • Michael Jacobs
        • Contact:
          • Phone Number: 702-597-9825
    • New York
      • New York, New York, United States, 10455
        • Recruiting
        • Equity Medical
        • Principal Investigator:
          • Alissa McInerney
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Phone Number: 630-981-1261
        • Principal Investigator:
          • Marc Gauthier
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy and Clinical Immunology Associates
        • Principal Investigator:
          • Michael Palumbo
        • Contact:
          • Phone Number: 412-833-4051
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Vanderbilt Asthma, Sinus and Allergy Program
        • Principal Investigator:
          • Elizaveta Kalaidina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneously (SC)
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031
Experimental: Brenipatide Dose 2
Brenipatide administered SC.
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
Time Frame: Baseline to Week 52
To assess the asthma exacerbation rate.
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Patient Reported Health Outcomes
Time Frame: Baseline, Week 52
Baseline, Week 52
Time to First Exacerbation
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in Weekly Mean Rescue Medication Use
Time Frame: Baseline, Week 52
Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Time Frame: Baseline to Week 52
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 20, 2025

First Submitted That Met QC Criteria

October 20, 2025

First Posted (Actual)

October 21, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27744
  • 2025-522640-41 (EudraCT Number)
  • J2S-MC-GZMR (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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