Pulmonary Disease, Chronic ObstructivePhase 2RENEW-COPDNCT07759245
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Brenipatide in people with Pulmonary Disease, Chronic Obstructive, run by Eli Lilly and Company at 127 sites in 18 countries.
Trial summary
The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- 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
- 606 participants
- Where
- 127 sitesin 18 countries
- Study dates
- 7 Aug 2026to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:
- Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years
- Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)/forced vital capacity (FVC) less than (<) 70 percent (%)
- Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2
- Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.
- Background double therapy [long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)] or triple therapy [inhaled corticosteroids (ICS) + LABA + LAMA)] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.
Who cannot join
- Have a known pre-existing, clinically important lung condition other than COPD.
- Have a current or recent acute, active infection before screening and up to randomization.
Trial locations and contacts
127 sites in 18 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
127 sites in 18 countries
United States18 sites, 18 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
484-707-6813
Surya Bhatt
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
617-732-8201
Carrie Pistenmaa
- Recruiting
Premier Pulmonary Critical Care and Sleep
Denison, Texas, 75020
469-714-9864
Sanober Kable
- Recruiting
National Jewish Health Medical Center
Denver, Colorado, 80206
Michael Wechsler
- Recruiting
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
814-940-1212
Sandeep Bansal
- Not yet recruiting
Baylor College of Medicine Medical Center
Houston, Texas, 77030
NICOLA HANANIA
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
317-278-0099
Cynthia Brown
- Recruiting
Paramount Clinical Research - Data Point Clinical Research
Kirkland, Washington, 98034
425-577-1107
Javier Nazar
- Recruiting
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067
817-907-7330
Adekunle Adekola
- Recruiting
Headlands Research-Twin Cities
Maplewood, Minnesota, 55109
Charlene McEvoy
- Recruiting
Millennium Medical Research - Miami
Miami, Florida, 33126
David Orta
- Recruiting
Deluxe Health Center
Miami Lakes, Florida, 33014
305-209-1268
Raiko Diaz
- Recruiting
IU Health Ball Memorial Hospital, Inc.
Muncie, Indiana, 47303
Sashank Kolli
- Recruiting
NewportNativeMD, Inc.
Newport Beach, California, 92663
949-791-8599
Ryan Klein
- Recruiting
Florida Institute For Clinical Research, LLC
Orlando, Florida, 32825
407-658-0966
Humberto Cruz
- Recruiting
Institute of HealthCare Assessment d/b/a Apex Clinical Research
San Diego, California, 92120
619-582-5564
Edward Federman
- Recruiting
Revive Research Institute, Inc.
Southfield, Michigan, 48075
248-829-3103
Syed Raza
- Recruiting
Axis Clinical Trials - Westchester
Westchester, Illinois, 60154
Mohammad Ghani
China12 sites, 12 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou, 014010
Gaizhen Ge
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Ting Yang
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Haiying Yan
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Dongxing Zhao
- Not yet recruiting
Jiangyin People's Hospital
Jiangyin, 214400
Chengying Liu
- Not yet recruiting
Jinan Central Hospital
Jinan, 250013
Xin Wang
- Recruiting
Pingxiang People's Hospital
Pingxiang, 337055
Xiangbo Shen
- Not yet recruiting
Shanghai General Hospital
Shanghai, 200080
Min Zhang
- Recruiting
ShenZhen People's Hospital
Shenzhen, 518020
lingwei wang
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
13132088076
Jie Cao
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004
Jie Zhang
- Not yet recruiting
The First People's Hospital of Xinxiang
Xinxiang, 453000
Chenlong Cao
India12 sites, 12 recruiting
- Not yet recruiting
Silver Touch Hospital
Ahmedabad, 380015
Bhargav Solanki
- Not yet recruiting
Motilal Nehru Medical College Hospital
Allahabād, 211002
JITENDRA SHUKLA
- Not yet recruiting
Medstar Speciality Hospital
Bangalore, 560092
Hirennappa B. Udnur
- Not yet recruiting
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal, 462024
Akash Pawar
- Not yet recruiting
Galaxy Superspeciality Hospital
Chhatrapati Sambhajinagar, 431001
Shreehas Bardapurkar
- Not yet recruiting
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010
Ajay Verma
- Not yet recruiting
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, 441108
Palanisamy Venkatachalam
- Not yet recruiting
All India Institute of Medical Sciences
New Delhi, 110029
Saurabh Mittal
- Not yet recruiting
Yatharth Super Speciality Hospital - Noida Extension
Noida, 201306
Puneet Gupta
- Not yet recruiting
Orchid Hospital - Pune
Pune, 411047
Ashish Goyal
- Not yet recruiting
Lifepoint Multispeciality Hospital
Pune, 411057
Dnyandeep Sarpe
- Not yet recruiting
Pacific Medical College & Hospital
Udaipur, 313001
Atul Luhadiya
France11 sites, 11 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Christophe Gut-Gobert
- Recruiting
Centre Hospitalier de Cholet
Cholet, 49325
JEREMIE POILANE
- Not yet recruiting
Henri Mondor Hospital
Créteil, 94000
Laurent BOYER
- Not yet recruiting
Chu Grenoble Alpes
La Tronche, 38700
Bruno Degano
- Not yet recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Gilles DEVOUASSOUX
- Recruiting
Hôpital Européen Marseille
Marseille, 13003
Herve PEGLIASCO
- Recruiting
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, 34090
Arnaud Bourdin
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75679
Nicolas Roche
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, 33600
MAEVA ZYSMAN
- Not yet recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, 31059
Nicolas Guibert
- Not yet recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511
Bruno RIBEIRO BAPTISTA
South Korea9 sites, 9 recruiting
- Not yet recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, 21431
01092747783
Ju Sang Kim
- Not yet recruiting
Chung-Ang University Hospital
Dongjak-gu, 06973
Jae-Woo Jung
- Not yet recruiting
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415
June Hong Ahn
- Not yet recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
82-2-2030-4338
Sang Haak Lee
- Not yet recruiting
Konkuk University Medical Center
Seoul, 05030
Kwang Ha Yoo
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Seiwon Lee
- Not yet recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
Jin Woo Kim
- Not yet recruiting
Ulsan University Hospital
Ulsan, 44033
Seung Won Ra
- Not yet recruiting
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, 26426
+82-33-741-1232
Sang-Ha Kim
Romania8 sites, 8 recruiting
- Not yet recruiting
Arensia Clinics S.R.L.
Bucharest, 011658
0735888505
Camelia Nita
- Recruiting
Delta Health Care
Bucharest, 014142
0723631713
Veronica Surlea
- Recruiting
Anima Speciality Medical Services
Bucharest, 061696
+40744317818
Magdalena Aurelia Ciobanu
- Not yet recruiting
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006
+40740145536
Andrei Lesan
- Recruiting
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj
Cluj-Napoca, 400371
0765413503
Manuela Magdau
- Recruiting
Spitalul de Boli Infecțioase Victor Babeș
Craiova, 200515
+40723570393
Dragos Nicolosu
- Recruiting
Spital de Pneumologie Dr. Lavinia Davidescu
Oradea, 410063
0040741141734
Lavinia Davidescu
- Not yet recruiting
Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Dr. Victor Babeş Timișoara
Timișoara, 300310
0721434044
Monica Marc
Germany7 sites, 7 recruiting
- Recruiting
Studienzentrum Dr. Keller
Frankfurt, 60389
Claus Keller
- Not yet recruiting
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
Frankfurt, 60596
4969695972580
Marc Oliver Kornmann
- Recruiting
ME Clinical Respiratory Research Hamburg
Hamburg, 22299
0049 40 46095194
Martin Ehlers
- Recruiting
Asklepios MVZ Bayern
Landsberg am Lech, 86899
498191-91680
Florian Fliedner
- Recruiting
Salvus - Klinische Studien GmbH
Leipzig, 04207
493412460313
Regina Deckelmann
- Not yet recruiting
IKF Pneumologie Mainz
Mainz, 55128
Stephanie Korn
- Recruiting
Private Practice - Dr. Marc Hoffgen, Dr. Olaf Kesterman, Dr. Frank Koesters & Dr. Steffen Bulicke
Rheine, 48431
Olaf Kestermann
Argentina6 sites, 6 recruiting
- Recruiting
Consultorios Médicos, Organización del Buen Ayre S.R.L.
Buenos Aires, 1425
+541168893232
Silvina Riva
- Recruiting
Centro Médico Viamonte
Buenos Aires, C1120AAC
01134329720
Walter Mattarucco
- Recruiting
Fundación Respirar
Buenos Aires, C1426ABP
+549115 800 5058
Pablo Doreski
- Recruiting
Fundacion Scherbovsky
Mendoza, 5500
+54 9 261 6013404
Pablo Saez Scherbovsky
- Recruiting
Instituto Médico Río Cuarto
Río Cuarto, X5800AEV
541131077237
Carolina Cappelletti
- Recruiting
Centro de Salud e Investigaciones Médicas
Santa Rosa, L6300
+54 9 2954 327542
Federico Promencio
Japan6 sites, 6 recruiting
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Kyushu Central Hospital
Fukuoka, 815-0032
81120023812
Hiroshi Koto
- Not yet recruiting
Aso Iizuka Hospital
Iizuka, 820-8505
81120023812
Kazunori Tobino
- Recruiting
Osaka Keisatsu Hospital
Osaka, 543-0042
81120023812
Suguru Yamamoto
- Not yet recruiting
Tohoku Medical and Pharmaceutical University Hospital
Sendai, 983-8512
81120023812
Tsutomu Tamada
- Recruiting
Yamaguchi University Hospital
Ube, 755-8505
81120023812
Kazuki Hamada
United Kingdom6 sites, 6 recruiting
- Recruiting
Cheadle Community Hospital
Cheadle, ST10 1NS
07452948414
Mark Stone
- Recruiting
Staploe Medical Centre
Ely, CB7 5JD
01353727690
Anthony Gunstone
- Recruiting
HMC Health Group - Meadows Centre for Health
Hounslow, TW4 7NJ
07946732168
Ivor Singh
- Recruiting
Queen Anne Street Medical Centre
London, W1T 6AH
02070343325
Brian Leaker
- Recruiting
Atlantic Medical
Penzance, TR18 3DX
07760 777022
Tom Graver
- Recruiting
Marine Lake Medical Practice
West Kirby, CH48 5AA
James Perry
Canada5 sites, 5 recruiting
- Not yet recruiting
Dynamic Drug Advancement
Ajax, L1S 2J5
3658859086
George Philteos
- Recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Colleen Maytham
- Recruiting
Diex Recherche Inc. Division Sherbrooke Est
Sherbrooke, J1L 0K3
Jean-louis Aube
- Not yet recruiting
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1
Pierre-Alexandre Menard
- Recruiting
Dr. Syed Anees Medicine Professional Corporation
Windsor, N8X 1T3
(519) 252-4448
Syed Anees
Denmark5 sites, 5 recruiting
- Not yet recruiting
Aalborg Universitetshospital, Syd
Aalborg, 9000
Weinreich Ulla
- Not yet recruiting
Bispebjerg Hospital
Copenhagen, 2400
Asger Sverrild
- Not yet recruiting
Hvidovre Hospital
Hvidovre, 2650
Charlotte Ulrik
- Not yet recruiting
Roskilde Sygehus
Roskilde, 4000
Christian Meyer
- Not yet recruiting
Vejle Sygehus
Vejle, 7100
Ole Hilberg
Hungary5 sites, 5 recruiting
- Not yet recruiting
Budapesti Uzsoki Utcai Kórház
Budapest, 1145
+3614673852
Csaba Mathe
- Recruiting
Bugbox & Med
Budapest, 1203
Melinda Nyiro
- Not yet recruiting
Koch Róbert Kórház és Rendelőintézet
Edelény, 3780
Melinda Szabo
- Recruiting
Erzsebet Gondozohaz
Gödöllő, 2100
0036707735946
Janos Mucsi
- Not yet recruiting
Infer-Med
Pécs, 7635
06306983137
Marta Papp
Austria4 sites, 4 recruiting
- Not yet recruiting
Private Practice - Dr. Robert Voves
Feldbach, 8330
004331523111
Robert Voves
- Not yet recruiting
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Daniel Doberer
- Not yet recruiting
Ordination für Lungenkrankheiten
Linz, 4020
0043732775160
Michael Würtz
- Not yet recruiting
Klinik Floridsdorf
Vienna, 1210
+431277002208
Arschang Valipour
Czechia4 sites, 4 recruiting
- Recruiting
MEDITRIAL s.r.o.
Jindichv Hradec, 377 01
Petr Kopecky
- Recruiting
Private Practice - Dr. Ilona Pavlišová
Miroslav, 671 72
MUDr.Ilona Pavlisova
- Recruiting
CCR Ostrava s.r.o
Ostrava, 702 00
Maksym Semeniuk
- Recruiting
Ordinace chorob plicních
Prague, 110 00
734131311
Zuzana Kovarikova
Mexico4 sites, 4 recruiting
- Not yet recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Alan Torres Wong
- Not yet recruiting
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070
529999204004
Carlos Colonia Cano
- Not yet recruiting
Unidad Medica para la Salud Integral Interior A
San Nicolás de los Garza, 66465
52 81-2471-9367
Rodolfo Posadas-Valay
- Not yet recruiting
Medimanage Research
Tlalpan, 14050
María León Rodríguez
Poland3 sites, 3 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276
Adam Kretowski
- 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
Puerto Rico2 sites, 2 recruiting
- Recruiting
San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, 00726
Edgardo Cartagena Ayala
- Recruiting
BRCR Global Puerto Rico
San Juan, 00907-1509
9394191158
Maria Betancourt Quiles
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 Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Brenipatide, Placebo, Standard of Care
- Keywords
- Emphysema, Chronic Bronchitis, Lung Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Brenipatide administered SC
PlaceboDrug
Placebo administered SC
Standard of CareDrug
SOC
| Study group | Role | What they receive |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC). Receives: Drug: Brenipatide; Drug: Standard of Care |
| Brenipatide Dose 2 | Experimental | Brenipatide high dose administered SC in combination with SOC. Receives: Drug: Brenipatide; Drug: Standard of Care |
| Placebo | Placebo comparator | Placebo administered SC in combination with SOC. Receives: Drug: Placebo; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
Measured: Baseline through Week 36
Secondary outcomes (3)
Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment
Measured: Baseline through Week 52
Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score
Measured: Baseline, Week 36, and Week 52
Change from Baseline in Pre-BD FEV₁
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start7 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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, Investigator
- Enrolment
- 606 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 1-317-615-4559 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
- NCT07759245
- Sponsor's protocol ID
- 27825
- Other IDs
- J2S-MC-GZMV, 2026-525480-41-00
- Acronym
- RENEW-COPD
- Status last verified
- Nov 2026
- First submitted
- 7 Aug 2026
- Last updated
- 5 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07759245
- Acronym / sponsor ID
- RENEW-COPD / 27825
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Emphysema, Chronic Bronchitis, Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Drug: Brenipatide, Drug: Standard of CareBrenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC). |
| Brenipatide Dose 2 | Experimental | Drug: Brenipatide, Drug: Standard of CareBrenipatide high dose administered SC in combination with SOC. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Standard of CarePlacebo administered SC in combination with SOC. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:
Key exclusion criteria (2 listed)
- Have a known pre-existing, clinically important lung condition other than COPD.
- Have a current or recent acute, active infection before screening and up to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrenipatideAlso: LY3537031Brenipatide administered SC | Drug | Brenipatide Dose 1, Brenipatide Dose 2 |
| PlaceboPlacebo administered SC | Drug | Placebo |
| Standard of CareSOC | Drug | Brenipatide Dose 1, Brenipatide Dose 2, Placebo |
Primary outcome
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: Baseline through Week 36
3 secondary outcomes
Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment
Time frame: Baseline through Week 52
Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score
Time frame: Baseline, Week 36, and Week 52
Change from Baseline in Pre-BD FEV₁
Time frame: Baseline through Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
127 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brenipatide in people with Pulmonary Disease, Chronic Obstructive, run by Eli Lilly and Company at 127 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 127 sites in United States, China, India, France, South Korea and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁) (time frame: Baseline through Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.