AsthmaPhase 2RENEW-AsthmaNCT07219173
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
A Phase 2 study testing Brenipatide in people with Asthma, run by Eli Lilly and Company at 119 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Brenipatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 531 participants
- Where
- 119 sitesin 12 countries
- Study dates
- 22 Oct 2025to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
119 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
119 sites in 12 countries
United States17 sites, 17 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dinah Foer
- Recruiting
Asthma & Allergy Associates - Colorado Springs
Colorado Springs, Colorado, 80907
Luke Webb
- Recruiting
AMR Clinical
Doral, Florida, 33172-2514
Abid Chaudhry
- Recruiting
AMR Clinical
Las Vegas, Nevada, 89119
702-597-9825
Michael Jacobs
- Not yet recruiting
Vanderbilt Asthma, Sinus and Allergy Program
Nashville, Tennessee, 37203
Ashley Wu
- Recruiting
Equity Medical
New York, New York, 10455
(908) - 303-9909
Alissa McInerney
- Recruiting
NewportNativeMD, Inc.
Newport Beach, California, 92663
9497918599
Ryan Klein
- Recruiting
California Medical Research Associates
Northridge, California, 91324
Sanjay Vadgama
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
3526295800
Raj Karunakara
- Recruiting
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301
2706846144
Lee Clore
- Recruiting
Avanza Medical Research Center
Pensacola, Florida, 32503
8504777900
Linda McCafferty
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
6309811261
Marc Gauthier
- Recruiting
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
4128334051
Michael Palumbo
- Recruiting
Peninsula Research Associates
Rolling Hills Estates, California, 90274
3102651623
Lawrence Sher
- Recruiting
USF Health
Tampa, Florida, 33613
8136314024
Thomas Casale
- Recruiting
AMR Clinical
Tempe, Arizona, 85281
6029103343
William Reedy
- Recruiting
Axis Clinical Trials - Westchester
Westchester, Illinois, 60154
Mohammad Ghani
China13 sites, 13 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou, 014010
Yao Ma
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020
Kewu Huang
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Gang Wang
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
13101363078
Shuliang Guo
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Yilan Sun
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, 330006
13576030963
Xiya Wu
- Recruiting
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, 211103
Xiuwei Zhang
- Recruiting
Shanghai General Hospital
Shanghai, 200080
Min Zhang
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053
Lei Rong
- Recruiting
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, 050000
zhigang cai
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
13132088076
Jie Cao
- Recruiting
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, 315100
Liqin Wu
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
Min Xie
Japan12 sites, 12 recruiting
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Osaka Habikino Medical Center
Habikino, 583-8588
81120023812
Osamu Matsuno
- Recruiting
Aso Iizuka Hospital
Iizuka, 820-8505
81120023812
Kazunori Tobino
- Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
81120023812
Takahiro Matsuyama
- Recruiting
Ishikawa Prefectural Central Hospital
Kanazawa, 920-8530
81120023812
Yoshihiro Takeda
- Recruiting
Kameari Internal Medicine and Respiratory Clinic
Katsushika-ku, 125-0061
81120023812
HARUHIKO YANAGISAWA
- Recruiting
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, 457-8510
81120023812
Shuichi Asano
- Recruiting
International University of Health and Welfare Narita Hospital
Narita, 286-8520
81120023812
Yasuo To
- Recruiting
Okayama University Hospital
Okayama, 700-8558
81120023812
Nobuaki Miyahara
- Recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
81120023812
Keiichi Fujiwara
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-8586
81120023812
Kazuhisa Asai
- Recruiting
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051
81120023812
Shigeru Komatsu
Argentina10 sites, 10 recruiting
- Recruiting
Consultorios Médicos, Organización del Buen Ayre S.R.L.
Buenos Aires, 1425
+541168893232
Silvina Riva
- Recruiting
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI
08003450697
Gonzalo Saenz
- Recruiting
Fundación Respirar
Buenos Aires, C1426ABP
+549115 800 5058
Pablo Doreski
- Recruiting
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, C1012AAR
541154143028
Ricardo del Olmo Sansone
- Recruiting
Instituto de Asma, Alergia y Enfermedades Respiratorias
Corrientes, 3400
+5493794391031
Alejandro Berardi
- Recruiting
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152
+5493416008195
Rodolfo Navarrete
- Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, B7600FZO
+54 9 2234 24-0652
Pablo Martinez Monferran
- Recruiting
Instituto Médico Río Cuarto
Río Cuarto, X5800AEV
541131077237
Carolina Cappelletti
- Recruiting
ABC Instituto de Diagnóstico
Rosario, 2000
54 341 397379
Adriana Marcipar
- Recruiting
Ibamedica
Santa Fe, 3000
543424564943
Martin Maillo
Brazil10 sites, 10 recruiting
- Recruiting
NewData Clinical Research - Aracaju
Aracaju, 49075-000
Ivan Mendes
- Recruiting
Private Practice - Dr. Nelson Rosário
Curitiba, 80810-100
5541 3208 6500
Nelson Rosario Filho
- Recruiting
Clinica de Pneumologia
Goiânia, 74110 030
Marcelo Rabahi
- Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
Bruno de Oliveira
- Recruiting
Hospital Universitário Onofre Lopes
Natal, 59012-300
Suzianne Pinto
- Recruiting
Instituto Atena de Pesquisa Clinica
Natal, 59020-500
Hugo Paiva
- Recruiting
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, 99010-120
55 54 3581 1831
Tiago Simon
- Recruiting
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, 14051-140
MARIA EDUARDA ZANETTI
- Recruiting
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180
+552125277979
Priscila Wolff
- Recruiting
Clinica de Alergia Martti Antila
Sorocaba, 18040-425
551535194909
MARTTI ANTILA
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence
Aix-en-Provence, 13100
Youssef TRIGUI
- Recruiting
CHRU de Brest
Brest, 29609
Raphael Le Mao
- Recruiting
Centre Hospitalier de Cholet
Cholet, 49325
Pauline BEURRIER
- Recruiting
Centre Hospitalier de Versailles André Mignot
Le Chesnay, 78157
0661073507
Gilles Garcia
- Recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Antoine Beurnier
- Recruiting
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, 93370
0141708160
Cyril Maurer
- Recruiting
Hôpital Bichat - Claude-Bernard
Paris, 75018
0684629275
Camille Taillé
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, 33600
+330557656039
Pierre-Olivier Girodet
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033
Chantal Belleguic
- Recruiting
Hôpital Foch
Suresnes, 92150
Céline Goyard
India10 sites, 10 recruiting
- Recruiting
Galaxy Superspeciality Hospital
Aurangabad, 431001
Shreehas Bardapurkar
- Recruiting
Mahatma Gandhi Mission Medical College
Aurangabad, 431003
+91-8390628800
Deshmukh Mohd
- Recruiting
Medstar Speciality Hospital
Bangalore, 560092
Hirennappa B. Udnur
- Recruiting
All India Institute of Medical Sciences
Bhubaneswar, 751019
Mahismita Patro
- Recruiting
Aakash Healthcare Private Limited
Dwārka, 110075
09910425552
Akshay Budhraja
- Recruiting
Atmaram Child Care
Kanpur, 208011
Arjun Bhatnagar
- Recruiting
All India Institute of Medical Sciences
New Delhi, 110029
Saurabh Mittal
- Recruiting
Lifepoint Multispeciality Hospital
Pune, 411057
+91-9028560535
Rajkumar Nikalje
- Recruiting
All India Institute of Medical Sciences
Raipur, 492099
Dibakar Sahu
- Recruiting
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001
Aman Ahuja
Mexico10 sites, 10 recruiting
- Recruiting
San Peregrino Unidad de Investigación
Aguascalientes, 20230
4491114337
MELISSA ONOFRE BORJA
- Recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Ilse Loya Barriga
- Recruiting
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
Edwin Daniel MALDONADO DOMINGUEZ
- Recruiting
Instituto Jalisciense de Investigación Clínica Sa de Cv
Guadalajara, 44100
Daniel Salazar Quiroz
- Not yet recruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
3331200700
Bertha Nachelly Gonzalez
- Not yet recruiting
Centro de Desarrollo Biomedico
Mérida, 97000
9992855178
Raul Bracamonte Peraza
- Recruiting
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070
529999204004
Carlos Colonia Cano
- Recruiting
Cicmex Centro de Investigación Clínica de México
Morelia, 58020
Marco Tafolla Manzo
- Not yet recruiting
Centro de Investigacion Clinica Chapultepec
Querétaro, 76088
PEDRO DANIEL ALVARADO
- Recruiting
FAICIC S. de R.L. de C.V.
Veracruz, 91900
2299327808
Luis Domínguez Sansores
Canada9 sites, 9 recruiting
- Recruiting
Dynamic Drug Advancement
Ajax, L1S 2J5
3658859086
George Philteos
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, L8N 4A6
Parameswaran Nair
- Recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Colleen Maytham
- Not yet recruiting
McGill University Health Centre
Montreal, H4A 3J1
Nermin Diab
- Recruiting
IUCPQ
Québec, G1V 4G5
Andreanne Cote
- Recruiting
Richmond Clinical Trials
Richmond, V6V 2L1
604-373-4954
Alexandra Lucas
- Recruiting
C.I.C. Saint-Laurent
Saint-Laurent, H4R 3C8
Isabel Coman
- Recruiting
Inspiration Research
Toronto, M5T 3A9
4169449602
Kenneth Chapman
- Recruiting
Dr. Syed Anees Medicine Professional Corporation
Windsor, N8X 1T3
(519) 252-4448
Syed Anees
Germany8 sites, 8 recruiting
- Recruiting
KPPK Studienzentrum
Bendorf, 56170
004926228983390
Olaf Schmidt
- Recruiting
Studienpraxis Berlin-Brandenburg Lennart Schaper
Berlin, 10119
+493044048226
Lennart Schaper
- Recruiting
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
Essen, 45239
00492014334503
Sivagurunathan Sutharsan
- Recruiting
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
Frankfurt, 60596
4969695972580
Andreas Eich
- Recruiting
ME Clinical Respiratory Research Hamburg
Hamburg, 22299
0049 40 46095194
Martin Ehlers
- Recruiting
POIS Sachsen
Leipzig, 04347
034160050650
Juliana Brode
- Recruiting
IKF Pneumologie Mainz
Mainz, 55128
Stephanie Korn
- Recruiting
FutureMeds Offenbach
Offenbach, 63065
0049 69 247433849
Christel Contzen
Netherlands6 sites, 6 recruiting
- Recruiting
EB Medical Research
Almere Stad, 1311 RL
31365468346
Mazin Alhakim
- Recruiting
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, 4818 CK
0031-76-5952383
Simone van der Sar - Brugge
- Not yet recruiting
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
0243658755
Juergen Hoelters
- Not yet recruiting
Franciscus Gasthuis & Vlietland, Locatie Gasthuis
Rotterdam, 3045 PM
0104616619
Gert-Jan Braunstahl
- Recruiting
Gelre Ziekenhuizen
Zutphen, 7207 AE
+31575592322
Martijn Goosens
- Not yet recruiting
Isala, locatie Zwolle
Zwolle, 8025 AB
0031 88 6243254
Kornelis Patberg
Poland4 sites, 4 recruiting
- Recruiting
Centrum Medyczne ,,All - Med'' Badania Kliniczne
Krakow, 30-033
48124223271
Grazyna Pulka
- Recruiting
Diamond Clinic
Krakow, 31-559
+ 48 696 049 029
Barbara Rewerska
- Recruiting
Alergologia Plus sp. z o.o.
Poznan, 60-693
+48616562160
Michal Springer
- Recruiting
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
Poznan, 61-578
+48 601 751 713
Danuta Madra-Rogacka
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Brenipatide, Placebo
- Keywords
- Incretin
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Administered SC
BrenipatideDrug
Also called LY3537031
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Brenipatide administered subcutaneously (SC) Receives: Drug: Brenipatide |
| Brenipatide Dose 2 | Experimental | Brenipatide administered SC. Receives: Drug: Brenipatide |
| Placebo | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
To assess the asthma exacerbation rate.
Measured: Baseline to Week 52
Secondary outcomes (6)
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)
Measured: Baseline, Week 52
Change from Baseline in Patient Reported Health Outcomes
Measured: Baseline, Week 52
Time to First Exacerbation
Measured: Baseline to Week 52
Change from Baseline in Weekly Mean Rescue Medication Use
Measured: Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Baseline up to Week 52
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start22 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 531 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219173
- Sponsor's protocol ID
- 27744
- Other IDs
- 2025-522640-41, J2S-MC-GZMR, 2025
- Acronym
- RENEW-Asthma
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.