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Can a new injection ease COPD and cut Flare-Ups?

NCT ID NCT07759245

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This trial is testing an investigational drug called brenipatide in adults with moderate-to-severe COPD. Participants will receive either brenipatide or a placebo for about a year, alongside standard care. The goal is to see if brenipatide improves lung function and reduces the number of COPD flare-ups compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brenipatide (an investigational drug given by injection)
What this could lead to
If successful, brenipatide could offer a new way to improve breathing and reduce COPD flare-ups, potentially adding a much-needed treatment option for people with moderate-to-severe disease.
What could go wrong
This is an early-stage (phase 2) trial, so the drug may not prove more effective than placebo. Possible side effects are still being evaluated, and results may not apply to all COPD patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 606 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic bronchitis chronic obstructive pulmonary disease COPD, severe early onset lung disorder pulmonary emphysema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary disease, chronic obstructive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    128 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg Universitetshospital, Syd

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital, Skejby

    Aarhus, 8200, Denmark

  • All India Institute of Medical Sciences

    New Delhi, 110029, India

  • Anima Speciality Medical Services

    Bucharest, 061696, Romania

  • Arensia Clinics S.R.L.

    Bucharest, 011658, Romania

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios MVZ Bayern

    Landsberg am Lech, 86899, Germany

  • Aso Iizuka Hospital

    Iizuka, 820-8505, Japan

  • Atlantic Medical

    Penzance, TR18 3DX, United Kingdom

  • Axis Clinical Trials - Westchester

    Westchester, Illinois, 60154, United States

  • BRCR Global Puerto Rico

    San Juan, 00907-1509, Puerto Rico

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145, Hungary

  • Bugbox & Med

    Budapest, 1203, Hungary

  • C.I.C. Mauricie inc.

    Trois-Rivières, G8T 7A1, Canada

  • CCR Ostrava s.r.o

    Ostrava, 702 00, Czechia

  • CHRU de Brest

    Brest, 29609, 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

  • Centre Hospitalier de Cholet

    Cholet, 49325, France

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC, Argentina

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, L6300, Argentina

  • Centrum Medyczne ,,All - Med'' Badania Kliniczne

    Krakow, 30-033, Poland

  • Cheadle Community Hospital

    Cheadle, ST10 1NS, United Kingdom

  • China-Japan Friendship Hospital

    Beijing, 100029, China

  • Chu Grenoble Alpes

    La Tronche, 38700, France

  • Chung-Ang University Hospital

    Dongjak-gu, 06973, South Korea

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801, United States

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

    Buenos Aires, 1425, Argentina

  • Delta Health Care

    Bucharest, 014142, Romania

  • Deluxe Health Center

    Miami Lakes, Florida, 33014, United States

  • Diamond Clinic

    Krakow, 31-559, Poland

  • Diex Recherche Inc. Division Sherbrooke Est

    Sherbrooke, J1L 0K3, Canada

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, 226010, India

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, N8X 1T3, Canada

  • Dynamic Drug Advancement

    Ajax, L1S 2J5, Canada

  • Erzsebet Gondozohaz

    Gödöllő, 2100, Hungary

  • Esbjerg sygehus, Syddansk Universitetshospital

    Esbjerg, 6700, Denmark

  • Florida Institute For Clinical Research, LLC

    Orlando, Florida, 32825, United States

  • Fundacion Scherbovsky

    Mendoza, 5500, Argentina

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • Galaxy Superspeciality Hospital

    Aurangabad, 431001, India

  • HMC Health Group - Meadows Centre for Health

    Hounslow, TW4 7NJ, United Kingdom

  • Headlands Research-Twin Cities

    Maplewood, Minnesota, 55109, United States

  • Henri Mondor Hospital

    Créteil, 94000, France

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75679, France

  • Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, 34090, France

  • Hôpital Européen Marseille

    Marseille, 13003, France

  • Hôpital de la Croix Rousse

    Lyon, 69004, France

  • IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T

    Frankfurt, 60596, Germany

  • IKF Pneumologie Mainz

    Mainz, 55128, Germany

  • IU Health Ball Memorial Hospital, Inc.

    Muncie, Indiana, 47303, United States

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Infer-Med

    Pécs, 7635, Hungary

  • Inspiration Research

    Toronto, M5T 3A9, Canada

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

    San Diego, California, 92120, United States

  • Instituto Médico Río Cuarto

    Río Cuarto, X5800AEV, Argentina

  • Jiangyin People's Hospital

    Jiangyin, 214400, China

  • Jinan Central Hospital

    Jinan, 250013, China

  • Kelowna Health and Memory Centre

    Kelowna, V1Y 5A8, Canada

  • Klinik Floridsdorf

    Vienna, 1210, Austria

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020, Austria

  • Koch Róbert Kórház és Rendelőintézet

    Edelény, 3780, Hungary

  • Kohler & Milstein Research S.A. De C.V.

    Mérida, 97070, Mexico

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Kyushu Central Hospital

    Fukuoka, 815-0032, Japan

  • Lifepoint Multispeciality Hospital

    Pune, 411057, India

  • ME Clinical Respiratory Research Hamburg

    Hamburg, 22299, Germany

  • MEDITRIAL s.r.o.

    Jindichv Hradec, 377 01, Czechia

  • Marine Lake Medical Practice

    West Kirby, CH48 5AA, United Kingdom

  • Medimanage Research

    Tlalpan, 14050, Mexico

  • Medstar Speciality Hospital

    Bangalore, 560092, India

  • Millennium Medical Research - Miami

    Miami, Florida, 33126, United States

  • Motilal Nehru Medical College Hospital

    Allahābād, 211002, India

  • National Jewish Health Medical Center

    Denver, Colorado, 80206, United States

  • NewportNativeMD, Inc.

    Newport Beach, California, 92663, United States

  • Orchid Hospital - Pune

    Pune, 411047, India

  • Ordinace chorob plicních

    Prague, 110 00, Czechia

  • Ordination für Lungenkrankheiten

    Linz, 4020, Austria

  • Osaka Keisatsu Hospital

    Osaka, 543-0042, Japan

  • Pacific Medical College & Hospital

    Udaipur, 313001, India

  • Paramount Clinical Research - Data Point Clinical Research

    Kirkland, Washington, 98034, United States

  • Pingxiang People's Hospital

    Pingxiang, 337055, China

  • Premier Pulmonary Critical Care and Sleep

    Denison, Texas, 75020, United States

  • Prime Clinical Research - Lewisville

    Lewisville, Texas, 75067, United States

  • Private Practice - Dr. Ilona Pavlišová

    Miroslav, 671 72, Czechia

  • Private Practice - Dr. Marc Hoffgen, Dr. Olaf Kesterman, Dr. Frank Koesters & Dr. Steffen Bulicke

    Rheine, 48431, Germany

  • Private Practice - Dr. Robert Voves

    Feldbach, 8330, Austria

  • Queen Anne Street Medical Centre

    London, W1T 6AH, United Kingdom

  • Revive Research Institute, Inc.

    Southfield, Michigan, 48075, United States

  • Roskilde Sygehus

    Roskilde, 4000, Denmark

  • Salvus - Klinische Studien GmbH

    Leipzig, 04207, Germany

  • San Juan Bautista School of Medicine - Clinical Research Unit

    Caguas, 00726, Puerto Rico

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207, Mexico

  • Shanghai General Hospital

    Shanghai, 200080, China

  • ShenZhen People's Hospital

    Shenzhen, 518020, China

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Silver Touch Hospital

    Ahmedabad, 380015, India

  • Spital de Pneumologie Dr. Lavinia Davidescu

    Oradea, 410063, Romania

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006, Romania

  • Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Dr. Victor Babeş Timișoara

    Timișoara, 300310, Romania

  • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj

    Cluj-Napoca, 400371, Romania

  • Spitalul de Boli Infecțioase Victor Babeș

    Craiova, 200515, Romania

  • Staploe Medical Centre

    Ely, CB7 5JD, United Kingdom

  • Studienzentrum Dr. Keller

    Frankfurt, 60389, Germany

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 03312, South Korea

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Bupyeong-gu, 21431, South Korea

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

    Baotou, 014010, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • The First People's Hospital of Xinxiang

    Xinxiang, 453000, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004, China

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, 983-8512, Japan

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027, Japan

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • Unidad Medica para la Salud Integral Interior A

    San Nicolás de los Garza, 66465, Mexico

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, 15-276, Poland

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Yamaguchi University Hospital

    Ube, 755-8505, Japan

  • Yatharth Super Speciality Hospital - Noida Extension

    Noida, 201306, India

  • Yeungnam Univeristy Medical Center

    Gyeongsan-si, 42415, South Korea

  • Yonsei University-Wonju Severance Christian Hospital

    Wŏnju, 26426, South Korea

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