A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
RENEW-COPD
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)
3 other identifiers
interventional
606
18 countries
127
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2026
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2026
CompletedStudy Start
First participant enrolled
August 7, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
September 25, 2026
September 1, 2026
1.7 years
August 7, 2026
September 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
Baseline through Week 36
Secondary Outcomes (3)
Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment
Baseline through Week 52
Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score
Baseline, Week 36, and Week 52
Change from Baseline in Pre-BD FEV₁
Baseline through Week 52
Study Arms (3)
Brenipatide Dose 1
EXPERIMENTALBrenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).
Brenipatide Dose 2
EXPERIMENTALBrenipatide high dose administered SC in combination with SOC.
Placebo
PLACEBO COMPARATORPlacebo administered SC in combination with SOC.
Interventions
Brenipatide administered SC
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NewportNativeMD, Inc.
Newport Beach, California, 92663, United States
Institute of HealthCare Assessment d/b/a Apex Clinical Research
San Diego, California, 92120, United States
National Jewish Health Medical Center
Denver, Colorado, 80206, United States
Millennium Medical Research - Miami
Miami, Florida, 33126, United States
Deluxe Health Center
Miami Lakes, Florida, 33014, United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, 32825, United States
Axis Clinical Trials - Westchester
Westchester, Illinois, 60154, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
IU Health Ball Memorial Hospital, Inc.
Muncie, Indiana, 47303, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Revive Research Institute, Inc.
Southfield, Michigan, 48075, United States
Headlands Research-Twin Cities
Maplewood, Minnesota, 55109, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801, United States
Premier Pulmonary Critical Care and Sleep
Denison, Texas, 75020, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067, United States
Paramount Clinical Research - Data Point Clinical Research
Kirkland, Washington, 98034, United States
Consultorios Médicos, Organización del Buen Ayre S.R.L.
Buenos Aires, 1425, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Fundacion Scherbovsky
Mendoza, 5500, Argentina
Instituto Médico Río Cuarto
Río Cuarto, X5800AEV, Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, L6300, Argentina
Private Practice - Dr. Robert Voves
Feldbach, 8330, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
Ordination für Lungenkrankheiten
Linz, 4020, Austria
Klinik Floridsdorf
Vienna, 1210, Austria
Dynamic Drug Advancement
Ajax, L1S 2J5, Canada
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8, Canada
Diex Recherche Inc. Division Sherbrooke Est
Sherbrooke, J1L 0K3, Canada
Inspiration Research
Toronto, M5T 3A9, Canada
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, N8X 1T3, Canada
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T
Baotou, 014010, China
China-Japan Friendship Hospital
Beijing, 100029, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Jiangyin People's Hospital
Jiangyin, 214400, China
Jinan Central Hospital
Jinan, 250013, China
Pingxiang People's Hospital
Pingxiang, 337055, China
Shanghai General Hospital
Shanghai, 200080, China
ShenZhen People's Hospital
Shenzhen, 518020, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
The First People's Hospital of Xinxiang
Xinxiang, 453000, China
MEDITRIAL s.r.o.
Jindichv Hradec, 377 01, Czechia
Private Practice - Dr. Ilona Pavlišová
Miroslav, 671 72, Czechia
CCR Ostrava s.r.o
Ostrava, 702 00, Czechia
Ordinace chorob plicních
Prague, 110 00, Czechia
Aalborg Universitetshospital, Syd
Aalborg, 9000, Denmark
Aarhus Universitetshospital, Skejby
Aarhus, 8200, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Roskilde Sygehus
Roskilde, 4000, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
CHRU de Brest
Brest, 29609, France
Centre Hospitalier de Cholet
Cholet, 49325, France
Henri Mondor Hospital
Créteil, 94000, France
Chu Grenoble Alpes
La Tronche, 38700, France
Hôpital de la Croix Rousse
Lyon, 69004, France
Hôpital Européen Marseille
Marseille, 13003, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, 34090, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75679, France
CHU Bordeaux Haut-Leveque
Pessac, 33600, France
CHU de Toulouse - Hopital Larrey
Toulouse, 31059, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Studienzentrum Dr. Keller
Frankfurt, 60389, Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T
Frankfurt, 60596, Germany
ME Clinical Respiratory Research Hamburg
Hamburg, 22299, Germany
Asklepios MVZ Bayern
Landsberg am Lech, 86899, Germany
Salvus - Klinische Studien GmbH
Leipzig, 04207, Germany
IKF Pneumologie Mainz
Mainz, 55128, Germany
Private Practice - Dr. Marc Hoffgen, Dr. Olaf Kesterman, Dr. Frank Koesters & Dr. Steffen Bulicke
Rheine, 48431, Germany
Budapesti Uzsoki Utcai Kórház
Budapest, 1145, Hungary
Bugbox & Med
Budapest, 1203, Hungary
Koch Róbert Kórház és Rendelőintézet
Edelény, 3780, Hungary
Erzsebet Gondozohaz
Gödöllő, 2100, Hungary
Infer-Med
Pécs, 7635, Hungary
Silver Touch Hospital
Ahmedabad, 380015, India
Motilal Nehru Medical College Hospital
Allahābād, 211002, India
Galaxy Superspeciality Hospital
Aurangabad, 431001, India
Medstar Speciality Hospital
Bangalore, 560092, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Yatharth Super Speciality Hospital - Noida Extension
Noida, 201306, India
Orchid Hospital - Pune
Pune, 411047, India
Lifepoint Multispeciality Hospital
Pune, 411057, India
Pacific Medical College & Hospital
Udaipur, 313001, India
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Kyushu Central Hospital
Fukuoka, 815-0032, Japan
Aso Iizuka Hospital
Iizuka, 820-8505, Japan
Osaka Keisatsu Hospital
Osaka, 543-0042, Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, 983-8512, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070, Mexico
Unidad Medica para la Salud Integral Interior A
San Nicolás de los Garza, 66465, Mexico
Medimanage Research
Tlalpan, 14050, Mexico
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276, Poland
Centrum Medyczne ,,All - Med'' Badania Kliniczne
Krakow, 30-033, Poland
Diamond Clinic
Krakow, 31-559, Poland
San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, 00726, Puerto Rico
BRCR Global Puerto Rico
San Juan, 00907-1509, Puerto Rico
Arensia Clinics S.R.L.
Bucharest, 011658, Romania
Delta Health Care
Bucharest, 014142, Romania
Anima Speciality Medical Services
Bucharest, 061696, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006, Romania
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj
Cluj-Napoca, 400371, Romania
Spitalul de Boli Infecțioase Victor Babeș
Craiova, 200515, Romania
Spital de Pneumologie Dr. Lavinia Davidescu
Oradea, 410063, Romania
Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Dr. Victor Babeş Timișoara
Timișoara, 300310, Romania
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, 21431, South Korea
Chung-Ang University Hospital
Dongjak-gu, 06973, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Cheadle Community Hospital
Cheadle, ST10 1NS, United Kingdom
Staploe Medical Centre
Ely, CB7 5JD, United Kingdom
HMC Health Group - Meadows Centre for Health
Hounslow, TW4 7NJ, United Kingdom
Queen Anne Street Medical Centre
London, W1T 6AH, United Kingdom
Atlantic Medical
Penzance, TR18 3DX, United Kingdom
Marine Lake Medical Practice
West Kirby, CH48 5AA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2026
First Posted
August 12, 2026
Study Start
August 7, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.