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NCT07759245From ClinicalTrials.govRecruiting

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

  • Pulmonary Disease, Chronic Obstructive

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Eli Lilly and Company
Enrolment target
606
Started
7 August 2026
Main results due
May 2028
Study sites
127
Registry updated
25 September 2026

Can you take part?

  • Ages 40 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(127)

  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

    Not yet recruiting

  • NewportNativeMD, Inc.

    Newport Beach, California, United States

    Recruiting

  • Institute of HealthCare Assessment d/b/a Apex Clinical Research

    San Diego, California, United States

    Recruiting

  • National Jewish Health Medical Center

    Denver, Colorado, United States

    Not yet recruiting

  • Millennium Medical Research - Miami

    Miami, Florida, United States

    Recruiting

  • Deluxe Health Center

    Miami Lakes, Florida, United States

    Recruiting

  • Florida Institute For Clinical Research, LLC

    Orlando, Florida, United States

    Recruiting

  • Axis Clinical Trials - Westchester

    Westchester, Illinois, United States

    Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana, United States

    Not yet recruiting

  • IU Health Ball Memorial Hospital, Inc.

    Muncie, Indiana, United States

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, United States

    Not yet recruiting

  • Revive Research Institute, Inc.

    Southfield, Michigan, United States

    Recruiting

  • Headlands Research-Twin Cities

    Maplewood, Minnesota, United States

    Recruiting

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, United States

    Recruiting

  • Premier Pulmonary Critical Care and Sleep

    Denison, Texas, United States

    Not yet recruiting

  • Baylor College of Medicine Medical Center

    Houston, Texas, United States

    Not yet recruiting

  • Prime Clinical Research - Lewisville

    Lewisville, Texas, United States

    Recruiting

  • Paramount Clinical Research - Data Point Clinical Research

    Kirkland, Washington, United States

    Recruiting

  • Consultorios Médicos, Organización del Buen Ayre S.R.L.

    Buenos Aires, Argentina

    Recruiting

  • Centro Médico Viamonte

    Buenos Aires, Argentina

    Recruiting

  • Fundación Respirar

    Buenos Aires, Argentina

    Not yet recruiting

  • Fundacion Scherbovsky

    Mendoza, Argentina

    Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Argentina

    Recruiting

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, Argentina

    Recruiting

  • Private Practice - Dr. Robert Voves

    Feldbach, Austria

    Not yet recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Austria

    Not yet recruiting

  • Ordination für Lungenkrankheiten

    Linz, Austria

    Not yet recruiting

  • Klinik Floridsdorf

    Vienna, Austria

    Not yet recruiting

  • Dynamic Drug Advancement

    Ajax, Canada

    Not yet recruiting

  • Kelowna Health and Memory Centre

    Kelowna, Canada

    Not yet recruiting

  • Diex Recherche Inc. Division Sherbrooke Est

    Sherbrooke, Canada

    Not yet recruiting

  • Inspiration Research

    Toronto, Canada

    Not yet recruiting

  • C.I.C. Mauricie inc.

    Trois-Rivières, Canada

    Not yet recruiting

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Canada

    Not yet recruiting

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T

    Baotou, China

    Not yet recruiting

  • China-Japan Friendship Hospital

    Beijing, China

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, China

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

    Not yet recruiting

  • Jiangyin People's Hospital

    Jiangyin, China

    Not yet recruiting

  • Jinan Central Hospital

    Jinan, China

    Not yet recruiting

  • Pingxiang People's Hospital

    Pingxiang, China

    Not yet recruiting

  • Shanghai General Hospital

    Shanghai, China

    Not yet recruiting

  • ShenZhen People's Hospital

    Shenzhen, China

    Not yet recruiting

  • Tianjin Medical University General Hospital

    Tianjin, China

    Not yet recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

    Not yet recruiting

  • The First People's Hospital of Xinxiang

    Xinxiang, China

    Not yet recruiting

  • MEDITRIAL s.r.o.

    Jindichv Hradec, Czechia

    Not yet recruiting

  • Private Practice - Dr. Ilona Pavlišová

    Miroslav, Czechia

    Not yet recruiting

  • CCR Ostrava s.r.o

    Ostrava, Czechia

    Not yet recruiting

  • Ordinace chorob plicních

    Prague, Czechia

    Not yet recruiting

  • Aalborg Universitetshospital, Syd

    Aalborg, Denmark

    Not yet recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, Denmark

    Not yet recruiting

  • Bispebjerg Hospital

    Copenhagen, Denmark

    Not yet recruiting

  • Hvidovre Hospital

    Hvidovre, Denmark

    Not yet recruiting

  • Roskilde Sygehus

    Roskilde, Denmark

    Not yet recruiting

  • Vejle Sygehus

    Vejle, Denmark

    Not yet recruiting

  • CHRU de Brest

    Brest, France

    Not yet recruiting

  • Centre Hospitalier de Cholet

    Cholet, France

    Not yet recruiting

  • Henri Mondor Hospital

    Créteil, France

    Not yet recruiting

  • Chu Grenoble Alpes

    La Tronche, France

    Not yet recruiting

Showing 60 of 127 sites — filter to narrow it down. 20 of the 127 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07759245. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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