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)
| Registry | NCT07759245, acronym RENEW-COPD |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 606 (Estimated) |
| Sponsor | Eli Lilly and Company (Industry) |
| Conditions | Pulmonary Disease, Chronic Obstructive |
| Interventions | Brenipatide, Placebo, Standard of Care (Drug) |
| Dates | start 2026-08-07, primary completion 2028-05-01 (estimated), completion 2028-11-01 (estimated), first posted 2026-08-12, last updated 2026-10-08 |
| Locations | 127 sites in United States, Argentina, Austria, Canada, China, Czechia, Denmark, France and 10 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Pulmonary Disease, Chronic Obstructive All trials of Brenipatide All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Brenipatide Dose 1 | Experimental | Drug: Brenipatide; Drug: Standard of Care | Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC). |
| Brenipatide Dose 2 | Experimental | Drug: Brenipatide; Drug: Standard of Care | Brenipatide high dose administered SC in combination with SOC. |
| Placebo | Placebo comparator | Drug: Placebo; Drug: Standard of Care | Placebo administered SC in combination with SOC. |
Sex: All, ages: 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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham, Alabama | United States | 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 | 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 | 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 | Recruiting |
| Diex Recherche Inc. Division Sherbrooke Est | Sherbrooke | Canada | 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 | 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 | Recruiting |
| Private Practice - Dr. Ilona Pavlišová | Miroslav | Czechia | Not yet recruiting |
| CCR Ostrava s.r.o | Ostrava | Czechia | Recruiting |
| Ordinace chorob plicních | Prague | Czechia | 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 |
| Hôpital de la Croix Rousse | Lyon | France | Not yet recruiting |
| Hôpital Européen Marseille | Marseille | France | Not yet recruiting |
| Hôpital Arnaud de Villeneuve - CHU Montpellier | Montpellier | France | Not yet recruiting |
| Hopitaux Universitaires Paris Centre-Hopital Cochin | Paris | France | Not yet recruiting |
| CHU Bordeaux Haut-Leveque | Pessac | France | Recruiting |
| CHU de Toulouse - Hopital Larrey | Toulouse | France | Not yet recruiting |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois | Vandœuvre-lès-Nancy | France | Not yet recruiting |
| Studienzentrum Dr. Keller | Frankfurt | Germany | Not yet recruiting |
| IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T | Frankfurt | Germany | Not yet recruiting |
| ME Clinical Respiratory Research Hamburg | Hamburg | Germany | Not yet recruiting |
| Asklepios MVZ Bayern | Landsberg am Lech | Germany | Recruiting |
| Salvus - Klinische Studien GmbH | Leipzig | Germany | Recruiting |
| IKF Pneumologie Mainz | Mainz | Germany | Not yet recruiting |
| Private Practice - Dr. Marc Hoffgen, Dr. Olaf Kesterman, Dr. Frank Koesters & Dr. Steffen Bulicke | Rheine | Germany | Not yet recruiting |
| Budapesti Uzsoki Utcai Kórház | Budapest | Hungary | Not yet recruiting |
| Bugbox & Med | Budapest | Hungary | Not yet recruiting |
| Koch Róbert Kórház és Rendelőintézet | Edelény | Hungary | Not yet recruiting |
| Erzsebet Gondozohaz | Gödöllő | Hungary | Not yet recruiting |
| Infer-Med | Pécs | Hungary | Not yet recruiting |
| Silver Touch Hospital | Ahmedabad | India | Not yet recruiting |
| Motilal Nehru Medical College Hospital | Allahābād | India | Not yet recruiting |
| Galaxy Superspeciality Hospital | Aurangabad | India | Not yet recruiting |
| Medstar Speciality Hospital | Bangalore | India | Not yet recruiting |
| Dr. Ram Manohar Lohia Institute of Medical Sciences | Lucknow | India | Not yet recruiting |
| All India Institute of Medical Sciences | New Delhi | India | Not yet recruiting |
| Yatharth Super Speciality Hospital - Noida Extension | Noida | India | Not yet recruiting |
| Orchid Hospital - Pune | Pune | India | Not yet recruiting |
| Lifepoint Multispeciality Hospital | Pune | India | Not yet recruiting |
| Pacific Medical College & Hospital | Udaipur | India | Not yet recruiting |
| Tokyo-Eki Center-building Clinic | Chūōku | Japan | Not yet recruiting |
| Kyushu Central Hospital | Fukuoka | Japan | Not yet recruiting |
| Aso Iizuka Hospital | Iizuka | Japan | Not yet recruiting |
| Osaka Keisatsu Hospital | Osaka | Japan | Not yet recruiting |
| Tohoku Medical and Pharmaceutical University Hospital | Sendai | Japan | Not yet recruiting |
| Yamaguchi University Hospital | Ube | Japan | Not yet recruiting |
| Scientia Investigacion Clinica S.C. | Chihuahua City | Mexico | Not yet recruiting |
| Kohler & Milstein Research S.A. De C.V. | Mérida | Mexico | Not yet recruiting |
| Unidad Medica para la Salud Integral Interior A | San Nicolás de los Garza | Mexico | Not yet recruiting |
| Medimanage Research | Tlalpan | Mexico | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | Poland | Recruiting |
27 more sites not listed.