A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (RENEW-COPD)

August 21, 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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

606

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

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

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
        • Principal Investigator:
          • Pablo Doreski
        • Contact:
          • Phone Number: +549115 800 5058
      • Buenos Aires, Argentina, C1120AAC
        • Centro Médico Viamonte
        • Contact:
          • Phone Number: 01134329720
        • Principal Investigator:
          • Walter Mattarucco
      • Buenos Aires, Argentina, 1425
        • Consultorios Médicos, Organización del Buen Ayre S.R.L.
        • Contact:
          • Phone Number: +541168893232
        • Principal Investigator:
          • Silvina Riva
      • Mendoza, Argentina, 5500
        • Fundación Scherbovsky
        • Principal Investigator:
          • Pablo Saez Scherbovsky
        • Contact:
          • Phone Number: +54 9 261 6013404
      • Río Cuarto, Argentina, X5800AEV
        • Instituto Medico Rio Cuarto
        • Contact:
          • Phone Number: 541131077237
        • Principal Investigator:
          • Carolina Cappelletti
      • Santa Rosa, Argentina, L6300
        • Centro de Salud e Investigaciones Médicas
        • Contact:
          • Phone Number: +54 9 2954 327542
        • Principal Investigator:
          • Federico Promencio
  • Austria
      • Feldbach, Austria, 8330
        • Private Practice - Dr. Robert Voves
        • Principal Investigator:
          • Robert Voves
        • Contact:
          • Phone Number: 004331523111
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee
        • Principal Investigator:
          • Daniel Doberer
      • Linz, Austria, 4020
        • Ordination für Lungenkrankheiten
        • Contact:
          • Phone Number: 0043732775160
        • Principal Investigator:
          • Michael Würtz
      • Vienna, Austria, 1210
        • Klinik Floridsdorf
        • Contact:
          • Phone Number: +431277002208
        • Principal Investigator:
          • Arschang Valipour
  • Canada
      • Ajax, Canada, L1S 2J5
        • Dynamic Drug Advancement
        • Principal Investigator:
          • George Philteos
        • Contact:
          • Phone Number: 3658859086
      • Kelowna, Canada, V1Y 5A8
        • Kelowna Health and Memory Centre
        • Principal Investigator:
          • Colleen Maytham
      • Sherbrooke, Canada, J1L 0K3
        • Diex Recherche Inc. Division Sherbrooke Est
        • Principal Investigator:
          • Jean-louis Aube
      • Toronto, Canada, M5T 3A9
        • Inspiration Research
        • Principal Investigator:
          • Kenneth Chapman
        • Contact:
          • Phone Number: 4169449602
      • Trois-Rivières, Canada, G8T 7A1
        • C.I.C. Mauricie inc.
        • Principal Investigator:
          • Pierre-Alexandre Menard
      • Windsor, Canada, N8X 1T3
        • Dr. Syed Anees Medicine Professional Corporation
        • Principal Investigator:
          • Syed Anees
        • Contact:
          • Phone Number: (519) 252-4448
  • China
      • Baotou, China, 014010
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
        • Principal Investigator:
          • Gaizhen Ge
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Principal Investigator:
          • Ting Yang
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Haiying Yan
      • Guangzhou, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Dongxing Zhao
      • Jiangyin, China, 214400
        • Jiangyin People's Hospital
        • Principal Investigator:
          • Chengying Liu
      • Jinan, China, 250013
        • Jinan Central Hospital
        • Principal Investigator:
          • Xin Wang
      • Pingxiang, China, 337055
        • Pingxiang People's Hospital
        • Principal Investigator:
          • Xiangbo Shen
      • Shanghai, China, 200080
        • Shanghai General Hospital
        • Principal Investigator:
          • Min Zhang
      • Shenzhen, China, 518020
        • ShenZhen People's Hospital
        • Principal Investigator:
          • lingwei wang
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
        • Contact:
          • Phone Number: 13132088076
        • Principal Investigator:
          • Jie Cao
      • Xi'an, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Jie Zhang
      • Xinxiang, China, 453000
        • The First People's Hospital of Xinxiang
        • Principal Investigator:
          • Chenlong Cao
  • Czechia
      • Jindichv Hradec, Czechia, 377 01
        • MEDITRIAL s.r.o.
        • Principal Investigator:
          • Petr Kopecky
      • Miroslav, Czechia, 671 72
        • Private Practice - Dr. Ilona Pavlišová
        • Principal Investigator:
          • MUDr.Ilona Pavlisova
      • Ostrava, Czechia, 702 00
        • CCR Ostrava s.r.o
        • Principal Investigator:
          • Maksym Semeniuk
      • Prague, Czechia, 110 00
        • Ordinace chorob plicních
        • Contact:
          • Phone Number: 734131311
        • Principal Investigator:
          • Zuzana Kovarikova
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetshospital, Syd
        • Principal Investigator:
          • Weinreich Ulla
      • Aarhus, Denmark, 8200
        • Aarhus Universitetshospital, Skejby
        • Principal Investigator:
          • Andreas Hvass
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
        • Principal Investigator:
          • Asger Sverrild
      • Esbjerg, Denmark, 6700
        • Esbjerg sygehus, Syddansk Universitetshospital
        • Principal Investigator:
          • finn rasmussen
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
        • Principal Investigator:
          • Charlotte Ulrik
      • Roskilde, Denmark, 4000
        • Roskilde Sygehus
        • Principal Investigator:
          • Christian Meyer
      • Vejle, Denmark, 7100
        • Vejle Sygehus
        • Principal Investigator:
          • Ole Hilberg
  • France
      • Brest, France, 29609
        • CHRU de Brest
        • Principal Investigator:
          • Christophe Gut-Gobert
      • Cholet, France, 49325
        • Centre Hospitalier de Cholet
        • Principal Investigator:
          • JEREMIE POILANE
      • Créteil, France, 94000
        • Henri Mondor Hospital
        • Principal Investigator:
          • Laurent BOYER
      • La Tronche, France, 38700
        • CHU Grenoble Alpes
        • Principal Investigator:
          • Bruno Degano
      • Lyon, France, 69004
        • Hopital de la croix rousse
        • Principal Investigator:
          • Gilles DEVOUASSOUX
      • Marseille, France, 13003
        • Hôpital Européen Marseille
        • Principal Investigator:
          • Herve PEGLIASCO
      • Montpellier, France, 34090
        • Hôpital Arnaud de Villeneuve - CHU Montpellier
        • Principal Investigator:
          • Arnaud Bourdin
      • Paris, France, 75679
        • Hopitaux Universitaires Paris Centre-Hopital Cochin
        • Principal Investigator:
          • Nicolas Roche
      • Pessac, France, 33600
        • CHU Bordeaux Haut-Leveque
        • Principal Investigator:
          • MAEVA ZYSMAN
      • Toulouse, France, 31059
        • CHU de Toulouse - Hopital Larrey
        • Principal Investigator:
          • Nicolas Guibert
      • Vandœuvre-lès-Nancy, France, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
        • Principal Investigator:
          • Bruno RIBEIRO BAPTISTA
  • Germany
      • Frankfurt, Germany, 60389
        • Studienzentrum Dr. Keller
        • Principal Investigator:
          • Claus Keller
      • Frankfurt, Germany, 60596
        • IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
        • Principal Investigator:
          • Marc Oliver Kornmann
        • Contact:
          • Phone Number: 4969695972580
      • Hamburg, Germany, 22299
        • ME Clinical Respiratory Research Hamburg
        • Principal Investigator:
          • Martin Ehlers
        • Contact:
          • Phone Number: 0049 40 46095194
      • Landsberg am Lech, Germany, 86899
        • Asklepios MVZ Bayern
        • Contact:
          • Phone Number: 498191-91680
        • Principal Investigator:
          • Florian Fliedner
      • Leipzig, Germany, 04207
        • Salvus - Klinische Studien GmbH
        • Principal Investigator:
          • Regina Deckelmann
        • Contact:
          • Phone Number: 493412460313
      • Mainz, Germany, 55128
        • IKF Pneumologie Mainz
        • Principal Investigator:
          • Stephanie Korn
      • Rheine, Germany, 48431
        • Private Practice - Dr. Marc Hoffgen, Dr. Olaf Kesterman, Dr. Frank Koesters & Dr. Steffen Bulicke
        • Principal Investigator:
          • Olaf Kestermann
  • Hungary
      • Budapest, Hungary, 1145
        • Budapesti Uzsoki Utcai Korhaz
        • Principal Investigator:
          • Csaba Mathe
        • Contact:
          • Phone Number: +3614673852
      • Budapest, Hungary, 1203
        • Bugbox & Med
        • Principal Investigator:
          • Melinda Nyiro
      • Edelény, Hungary, 3780
        • Koch Róbert Kórház és Rendelőintézet
        • Principal Investigator:
          • Melinda Szabo
      • Gödöllő, Hungary, 2100
        • Erzsebet Gondozohaz
        • Principal Investigator:
          • Janos Mucsi
        • Contact:
          • Phone Number: 0036707735946
      • Pécs, Hungary, 7635
        • Infer-Med
        • Principal Investigator:
          • Marta Papp
        • Contact:
          • Phone Number: 06306983137
  • India
      • Ahmedabad, India, 380015
        • Silver Touch Hospital
        • Principal Investigator:
          • Bhargav Solanki
      • Allahābād, India, 211002
        • Motilal Nehru Medical College Hospital
        • Principal Investigator:
          • JITENDRA SHUKLA
      • Aurangabad, India, 431001
        • Galaxy Superspeciality Hospital
        • Principal Investigator:
          • Shreehas Bardapurkar
      • Bangalore, India, 560092
        • Medstar Speciality Hospital
        • Principal Investigator:
          • Hirennappa B. Udnur
      • Lucknow, India, 226010
        • Dr. Ram Manohar Lohia Institute of Medical Sciences
        • Principal Investigator:
          • Ajay Verma
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Saurabh Mittal
      • Noida, India, 201306
        • Yatharth Super Speciality Hospital - Noida Extension
        • Principal Investigator:
          • Puneet Gupta
      • Pune, India, 411057
        • Lifepoint Multispeciality Hospital
        • Principal Investigator:
          • Dnyandeep Sarpe
      • Pune, India, 411047
        • Orchid Hospital - Pune
        • Principal Investigator:
          • Ashish Goyal
      • Udaipur, India, 313001
        • Pacific Medical College & Hospital
        • Principal Investigator:
          • Atul Luhadiya
  • Japan
      • Chūōku, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Arihiro Kiyosue
      • Fukuoka, Japan, 815-0032
        • Kyushu Central Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroshi Koto
      • Iizuka, Japan, 820-8505
        • Aso Iizuka Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazunori Tobino
      • Osaka, Japan, 543-0042
        • Osaka Keisatsu Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Suguru Yamamoto
      • Sendai, Japan, 983-8512
        • Tohoku Medical and Pharmaceutical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tsutomu Tamada
      • Ube, Japan, 755-8505
        • Yamaguchi University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazuki Hamada
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Alan Torres Wong
      • Mérida, Mexico, 97070
        • Kohler & Milstein Research S.A. De C.V.
        • Contact:
          • Phone Number: 529999204004
        • Principal Investigator:
          • Carlos Colonia Cano
      • San Nicolás de los Garza, Mexico, 66465
        • Unidad Medica para la Salud Integral Interior A
        • Contact:
          • Phone Number: 52 81-2471-9367
        • Principal Investigator:
          • Rodolfo Posadas-Valay
      • Tlalpan, Mexico, 14050
        • Medimanage Research
        • Principal Investigator:
          • María León Rodríguez
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny W Białymstoku
        • Principal Investigator:
          • Adam Kretowski
      • Krakow, Poland, 31-559
        • Diamond Clinic
        • Principal Investigator:
          • Barbara Rewerska
        • Contact:
          • Phone Number: + 48 696 049 029
      • Krakow, Poland, 30-033
        • Centrum Medyczne ,,All - Med'' Badania Kliniczne
        • Principal Investigator:
          • Grazyna Pulka
        • Contact:
          • Phone Number: 48124223271
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • San Juan Bautista School of Medicine - Clinical Research Unit
        • Principal Investigator:
          • Edgardo Cartagena Ayala
      • San Juan, Puerto Rico, 00907-1509
        • BRCR Global Puerto Rico
        • Contact:
          • Phone Number: 9394191158
        • Principal Investigator:
          • Maria Betancourt Quiles
  • Romania
      • Bucharest, Romania, 014142
        • Delta Health Care
        • Principal Investigator:
          • Veronica Surlea
        • Contact:
          • Phone Number: 0723631713
      • Bucharest, Romania, 011658
        • Arensia Clinics S.R.L.
        • Principal Investigator:
          • Camelia Nita
        • Contact:
          • Phone Number: 0735888505
      • Bucharest, Romania, 061696
        • Anima Speciality Medical Services
        • Contact:
          • Phone Number: +40744317818
        • Principal Investigator:
          • Magdalena Aurelia Ciobanu
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
        • Principal Investigator:
          • Andrei Lesan
        • Contact:
          • Phone Number: +40740145536
      • Cluj-Napoca, Romania, 400371
        • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj
        • Principal Investigator:
          • Manuela Magdau
        • Contact:
          • Phone Number: 0765413503
      • Craiova, Romania, 200515
        • Spitalul de Boli Infecțioase Victor Babeș
        • Principal Investigator:
          • Dragos Nicolosu
        • Contact:
          • Phone Number: +40723570393
      • Oradea, Romania, 410063
        • Spital de Pneumologie Dr. Lavinia Davidescu
        • Principal Investigator:
          • Lavinia Davidescu
        • Contact:
          • Phone Number: 0040741141734
      • Timișoara, Romania, 300310
        • Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
        • Contact:
          • Phone Number: 0721434044
        • Principal Investigator:
          • Monica Marc
  • South Korea
      • Bupyeong-gu, South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Principal Investigator:
          • Ju Sang Kim
        • Contact:
          • Phone Number: 01092747783
      • Dongjak-gu, South Korea, 06973
        • Chung-Ang University Hospital
        • Principal Investigator:
          • Jae-Woo Jung
      • Gyeongsan-si, South Korea, 42415
        • Yeungnam Univeristy Medical Center
        • Principal Investigator:
          • June Hong Ahn
      • Seoul, South Korea, 05505
        • Asan Medical Center
        • Principal Investigator:
          • Seiwon Lee
      • Seoul, South Korea, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Principal Investigator:
          • Jin Woo Kim
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center
        • Principal Investigator:
          • Kwang Ha Yoo
      • Seoul, South Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Principal Investigator:
          • Sang Haak Lee
        • Contact:
          • Phone Number: 82-2-2030-4338
      • Ulsan, South Korea, 44033
        • Ulsan university hospital
        • Principal Investigator:
          • Seung Won Ra
      • Wŏnju, South Korea, 26426
        • Yonsei University-Wonju Severance Christian Hospital
        • Principal Investigator:
          • Sang-Ha Kim
        • Contact:
          • Phone Number: +82-33-741-1232
  • United Kingdom
      • Cheadle, United Kingdom, ST10 1NS
        • Cheadle Community Hospital
        • Principal Investigator:
          • Mark Stone
        • Contact:
          • Phone Number: 07452948414
      • Ely, United Kingdom, CB7 5JD
        • Staploe Medical Centre
        • Contact:
          • Phone Number: 01353727690
        • Principal Investigator:
          • Anthony Gunstone
      • Hounslow, United Kingdom, TW4 7NJ
        • HMC Health Group - Meadows Centre for Health
        • Principal Investigator:
          • Ivor Singh
        • Contact:
          • Phone Number: 07946732168
      • London, United Kingdom, W1T 6AH
        • Queen Anne Street Medical Centre
        • Principal Investigator:
          • Brian Leaker
        • Contact:
          • Phone Number: 02070343325
      • Penzance, United Kingdom, TR18 3DX
        • Atlantic Medical
        • Contact:
          • Phone Number: 07760 777022
        • Principal Investigator:
          • Tom Graver
      • West Kirby, United Kingdom, CH48 5AA
        • Marine Lake Medical Practice
        • Principal Investigator:
          • James Perry
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
        • Contact:
          • Phone Number: 484-707-6813
        • Principal Investigator:
          • Surya Bhatt
    • California
      • Newport Beach, California, United States, 92663
        • NewportNativeMD, Inc.
        • Contact:
          • Phone Number: 949-791-8599
        • Principal Investigator:
          • Ryan Klein
      • San Diego, California, United States, 92120
        • Institute of HealthCare Assessment d/b/a Apex Clinical Research
        • Contact:
          • Phone Number: 619-582-5564
        • Principal Investigator:
          • Edward Federman
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health Medical Center
        • Principal Investigator:
          • Michael Wechsler
    • Florida
      • Miami, Florida, United States, 33126
        • Millennium Medical Research - Miami
        • Principal Investigator:
          • David Orta
      • Miami Lakes, Florida, United States, 33014
        • Deluxe Health Center
        • Contact:
          • Phone Number: 305-209-1268
        • Principal Investigator:
          • Raiko Diaz
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical Research, LLC
        • Contact:
          • Phone Number: 407-658-0966
        • Principal Investigator:
          • Humberto Cruz
    • Illinois
      • Westchester, Illinois, United States, 60154
        • Axis Clinical Trials - Westchester
        • Principal Investigator:
          • Mohammad Ghani
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
        • Contact:
          • Phone Number: 317-278-0099
        • Principal Investigator:
          • Cynthia Brown
      • Muncie, Indiana, United States, 47303
        • IU Health Ball Memorial Hospital, Inc.
        • Principal Investigator:
          • Sashank Kolli
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
        • Contact:
          • Phone Number: 617-732-8201
        • Principal Investigator:
          • Carrie Pistenmaa
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Revive Research Institute, Inc.
        • Principal Investigator:
          • Syed Raza
        • Contact:
          • Phone Number: 248-829-3103
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Headlands Research-Twin Cities
        • Principal Investigator:
          • Charlene McEvoy
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA
        • Principal Investigator:
          • Sandeep Bansal
        • Contact:
          • Phone Number: 814-940-1212
    • Texas
      • Denison, Texas, United States, 75020
        • Premier Pulmonary Critical Care and Sleep
        • Principal Investigator:
          • Sanober Kable
        • Contact:
          • Phone Number: 469-714-9864
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Medical Center
        • Principal Investigator:
          • NICOLA HANANIA
      • Lewisville, Texas, United States, 75067
        • Prime Clinical Research - Lewisville
        • Contact:
          • Phone Number: 817-907-7330
        • Principal Investigator:
          • Adekunle Adekola
    • Washington
      • Kirkland, Washington, United States, 98034
        • Paramount Clinical Research - Data Point Clinical Research
        • Principal Investigator:
          • Javier Nazar
        • Contact:
          • Phone Number: 425-577-1107

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:

  • 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.

Exclusion Criteria:

  • 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.

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
Experimental: Brenipatide Dose 1
Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).
Drug: Brenipatide
Brenipatide administered SC
Other Names:
  • LY3537031
Drug: Standard of Care
SOC
Experimental: Brenipatide Dose 2
Brenipatide high dose administered SC in combination with SOC.
Drug: Brenipatide
Brenipatide administered SC
Other Names:
  • LY3537031
Drug: Standard of Care
SOC
Placebo Comparator: Placebo
Placebo administered SC in combination with SOC.
Drug: Placebo
Placebo administered SC
Drug: Standard of Care
SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
Time Frame: Baseline through Week 36
Baseline through Week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment
Time Frame: Baseline through Week 52
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
Baseline, Week 36, and Week 52
Change from Baseline in Pre-BD FEV₁
Time Frame: Baseline through Week 52
Baseline through 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 1-317-615-4559 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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

August 7, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27825
  • J2S-MC-GZMV (Other Identifier: Eli Lilly and Company)
  • 2026-525480-41-00 (Ctis)

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.

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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