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

NCT07759245 — Phase 2, Recruiting, 606 participants, Eli Lilly and Company

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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)

RegistryNCT07759245, acronym RENEW-COPD
StatusRecruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment606 (Estimated)
SponsorEli Lilly and Company (Industry)
ConditionsPulmonary Disease, Chronic Obstructive
InterventionsBrenipatide, Placebo, Standard of Care (Drug)
Datesstart 2026-08-07, primary completion 2028-05-01 (estimated), completion 2028-11-01 (estimated), first posted 2026-08-12, last updated 2026-10-08
Locations127 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

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Brenipatide Dose 1ExperimentalDrug: Brenipatide; Drug: Standard of CareBrenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).
Brenipatide Dose 2ExperimentalDrug: Brenipatide; Drug: Standard of CareBrenipatide high dose administered SC in combination with SOC.
PlaceboPlacebo comparatorDrug: Placebo; Drug: Standard of CarePlacebo administered SC in combination with SOC.
  • Brenipatide (Drug), also known as LY3537031: Brenipatide administered SC
  • Placebo (Drug): Placebo administered SC
  • Standard of Care (Drug): SOC

+Outcome measures

Primary outcomes

  • Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁) [Baseline through Week 36]

Secondary outcomes

  • 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]

+Eligibility

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.

+Locations (127)

FacilityCityCountryStatus
University of Alabama at BirminghamBirmingham, AlabamaUnited StatesRecruiting
NewportNativeMD, Inc.Newport Beach, CaliforniaUnited StatesRecruiting
Institute of HealthCare Assessment d/b/a Apex Clinical ResearchSan Diego, CaliforniaUnited StatesRecruiting
National Jewish Health Medical CenterDenver, ColoradoUnited StatesNot yet recruiting
Millennium Medical Research - MiamiMiami, FloridaUnited StatesRecruiting
Deluxe Health CenterMiami Lakes, FloridaUnited StatesRecruiting
Florida Institute For Clinical Research, LLCOrlando, FloridaUnited StatesRecruiting
Axis Clinical Trials - WestchesterWestchester, IllinoisUnited StatesRecruiting
Indiana University Health University HospitalIndianapolis, IndianaUnited StatesRecruiting
IU Health Ball Memorial Hospital, Inc.Muncie, IndianaUnited StatesRecruiting
Brigham and Women's HospitalBoston, MassachusettsUnited StatesNot yet recruiting
Revive Research Institute, Inc.Southfield, MichiganUnited StatesRecruiting
Headlands Research-Twin CitiesMaplewood, MinnesotaUnited StatesRecruiting
Clinical Research Associates of Central PADuBois, PennsylvaniaUnited StatesRecruiting
Premier Pulmonary Critical Care and SleepDenison, TexasUnited StatesNot yet recruiting
Baylor College of Medicine Medical CenterHouston, TexasUnited StatesNot yet recruiting
Prime Clinical Research - LewisvilleLewisville, TexasUnited StatesRecruiting
Paramount Clinical Research - Data Point Clinical ResearchKirkland, WashingtonUnited StatesRecruiting
Consultorios Médicos, Organización del Buen Ayre S.R.L.Buenos AiresArgentinaRecruiting
Centro Médico ViamonteBuenos AiresArgentinaRecruiting
Fundación RespirarBuenos AiresArgentinaRecruiting
Fundacion ScherbovskyMendozaArgentinaRecruiting
Instituto Médico Río CuartoRío CuartoArgentinaRecruiting
Centro de Salud e Investigaciones MédicasSanta RosaArgentinaRecruiting
Private Practice - Dr. Robert VovesFeldbachAustriaNot yet recruiting
Klinikum Klagenfurt am WörtherseeKlagenfurtAustriaNot yet recruiting
Ordination für LungenkrankheitenLinzAustriaNot yet recruiting
Klinik FloridsdorfViennaAustriaNot yet recruiting
Dynamic Drug AdvancementAjaxCanadaNot yet recruiting
Kelowna Health and Memory CentreKelownaCanadaRecruiting
Diex Recherche Inc. Division Sherbrooke EstSherbrookeCanadaRecruiting
Inspiration ResearchTorontoCanadaNot yet recruiting
C.I.C. Mauricie inc.Trois-RivièresCanadaNot yet recruiting
Dr. Syed Anees Medicine Professional CorporationWindsorCanadaRecruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -TBaotouChinaNot yet recruiting
China-Japan Friendship HospitalBeijingChinaNot yet recruiting
Sichuan Provincial People's HospitalChengduChinaNot yet recruiting
The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhouChinaNot yet recruiting
Jiangyin People's HospitalJiangyinChinaNot yet recruiting
Jinan Central HospitalJinanChinaNot yet recruiting
Pingxiang People's HospitalPingxiangChinaNot yet recruiting
Shanghai General HospitalShanghaiChinaNot yet recruiting
ShenZhen People's HospitalShenzhenChinaNot yet recruiting
Tianjin Medical University General HospitalTianjinChinaNot yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'anChinaNot yet recruiting
The First People's Hospital of XinxiangXinxiangChinaNot yet recruiting
MEDITRIAL s.r.o.Jindichv HradecCzechiaRecruiting
Private Practice - Dr. Ilona PavlišováMiroslavCzechiaNot yet recruiting
CCR Ostrava s.r.oOstravaCzechiaRecruiting
Ordinace chorob plicníchPragueCzechiaRecruiting
Aalborg Universitetshospital, SydAalborgDenmarkNot yet recruiting
Aarhus Universitetshospital, SkejbyAarhusDenmarkNot yet recruiting
Bispebjerg HospitalCopenhagenDenmarkNot yet recruiting
Hvidovre HospitalHvidovreDenmarkNot yet recruiting
Roskilde SygehusRoskildeDenmarkNot yet recruiting
Vejle SygehusVejleDenmarkNot yet recruiting
CHRU de BrestBrestFranceNot yet recruiting
Centre Hospitalier de CholetCholetFranceNot yet recruiting
Henri Mondor HospitalCréteilFranceNot yet recruiting
Chu Grenoble AlpesLa TroncheFranceNot yet recruiting
Hôpital de la Croix RousseLyonFranceNot yet recruiting
Hôpital Européen MarseilleMarseilleFranceNot yet recruiting
Hôpital Arnaud de Villeneuve - CHU MontpellierMontpellierFranceNot yet recruiting
Hopitaux Universitaires Paris Centre-Hopital CochinParisFranceNot yet recruiting
CHU Bordeaux Haut-LevequePessacFranceRecruiting
CHU de Toulouse - Hopital LarreyToulouseFranceNot yet recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de BraboisVandœuvre-lès-NancyFranceNot yet recruiting
Studienzentrum Dr. KellerFrankfurtGermanyNot yet recruiting
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -TFrankfurtGermanyNot yet recruiting
ME Clinical Respiratory Research HamburgHamburgGermanyNot yet recruiting
Asklepios MVZ BayernLandsberg am LechGermanyRecruiting
Salvus - Klinische Studien GmbHLeipzigGermanyRecruiting
IKF Pneumologie MainzMainzGermanyNot yet recruiting
Private Practice - Dr. Marc Hoffgen, Dr. Olaf Kesterman, Dr. Frank Koesters & Dr. Steffen BulickeRheineGermanyNot yet recruiting
Budapesti Uzsoki Utcai KórházBudapestHungaryNot yet recruiting
Bugbox & MedBudapestHungaryNot yet recruiting
Koch Róbert Kórház és RendelőintézetEdelényHungaryNot yet recruiting
Erzsebet GondozohazGödöllőHungaryNot yet recruiting
Infer-MedPécsHungaryNot yet recruiting
Silver Touch HospitalAhmedabadIndiaNot yet recruiting
Motilal Nehru Medical College HospitalAllahābādIndiaNot yet recruiting
Galaxy Superspeciality HospitalAurangabadIndiaNot yet recruiting
Medstar Speciality HospitalBangaloreIndiaNot yet recruiting
Dr. Ram Manohar Lohia Institute of Medical SciencesLucknowIndiaNot yet recruiting
All India Institute of Medical SciencesNew DelhiIndiaNot yet recruiting
Yatharth Super Speciality Hospital - Noida ExtensionNoidaIndiaNot yet recruiting
Orchid Hospital - PunePuneIndiaNot yet recruiting
Lifepoint Multispeciality HospitalPuneIndiaNot yet recruiting
Pacific Medical College & HospitalUdaipurIndiaNot yet recruiting
Tokyo-Eki Center-building ClinicChūōkuJapanNot yet recruiting
Kyushu Central HospitalFukuokaJapanNot yet recruiting
Aso Iizuka HospitalIizukaJapanNot yet recruiting
Osaka Keisatsu HospitalOsakaJapanNot yet recruiting
Tohoku Medical and Pharmaceutical University HospitalSendaiJapanNot yet recruiting
Yamaguchi University HospitalUbeJapanNot yet recruiting
Scientia Investigacion Clinica S.C.Chihuahua CityMexicoNot yet recruiting
Kohler & Milstein Research S.A. De C.V.MéridaMexicoNot yet recruiting
Unidad Medica para la Salud Integral Interior ASan Nicolás de los GarzaMexicoNot yet recruiting
Medimanage ResearchTlalpanMexicoNot yet recruiting
Uniwersytecki Szpital Kliniczny w BiałymstokuBialystokPolandRecruiting

27 more sites not listed.

+Investigators

  • 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), Study director, Eli Lilly and Company