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NCT07759245PHASE2Recruiting

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

Eli Lilly and Company

Start Date

8/7/2026

Completion Date

11/1/2028

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.

Eligibility Criteria

Age Range: 40 years to 75 years

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.

Interventions

DRUG

Brenipatide

DRUG

Placebo

DRUG

Standard of Care

Interested in This Trial?

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Conditions

Pulmonary Disease, Chronic Obstructive

Locations

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