> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-brenipatide-ly3537031-in-adult-participants-with-62296ecc-0ea5-4432-97e0-51148f316213 > Record changed: 2026-10-13 # A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) NCT07759245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) Participants 606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) Start date 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) Number of sites 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Acronym** RENEW-COPD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Short title** A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Dates **Completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **First posted** 2026-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Primary completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Start date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Size and sites **Participants** 606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Planned participants** 606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Number of sites** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Identifiers **Registry ID** NCT07759245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **ClinicalTrials.gov ID** NCT07759245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Outcomes ### Primary outcomes 1. Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁) Timeframe: Baseline through Week 36 ### Secondary outcomes 1. Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment Timeframe: Baseline through Week 52 2. Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score Timeframe: Baseline, Week 36, and Week 52 3. Change from Baseline in Pre-BD FEV₁ Timeframe: Baseline through Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Sites - University of Alabama at BirminghamBirmingham, United States - NewportNativeMD, Inc.Newport Beach, United States - Institute of HealthCare Assessment d/b/a Apex Clinical ResearchSan Diego, United States - National Jewish Health Medical CenterDenver, United States - Millennium Medical Research - MiamiMiami, United States - Deluxe Health CenterMiami Lakes, United States - Florida Institute For Clinical Research, LLCOrlando, United States - Axis Clinical Trials - WestchesterWestchester, United States - Indiana University Health University HospitalIndianapolis, United States - IU Health Ball Memorial Hospital, Inc.Muncie, United States - Brigham and Women's HospitalBoston, United States - Revive Research Institute, Inc.Southfield, United States - Headlands Research-Twin CitiesMaplewood, United States - Clinical Research Associates of Central PADuBois, United States - Premier Pulmonary Critical Care and SleepDenison, United States - Baylor College of Medicine Medical CenterHouston, United States - Prime Clinical Research - LewisvilleLewisville, United States - Paramount Clinical Research - Data Point Clinical ResearchKirkland, United States - Consultorios Médicos, Organización del Buen Ayre S.R.L.Buenos Aires, Argentina - Centro Médico ViamonteBuenos Aires, Argentina - Fundación RespirarBuenos Aires, Argentina - Fundacion ScherbovskyMendoza, Argentina - Instituto Médico Río CuartoRío Cuarto, Argentina - Centro de Salud e Investigaciones MédicasSanta Rosa, Argentina - Feldbach, Austria And 103 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## References ### Other registry identifiers (2) - 2026-525480-41-00 - J2S-MC-GZMV Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07759245) ## Related records ### Drugs (1) - [Telbivudine](https://trialight.com/data/asset/telbivudine-5718dabe-4058-4559-b924-29d47b6e47ed.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (4) - [Chronic bronchitis](https://trialight.com/data/condition/chronic-bronchitis-1182c6a7-3657-5c56-89e7-6c969a2220da.md) - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) Primary condition - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) - [Pulmonary emphysema](https://trialight.com/data/condition/pulmonary-emphysema-7c09e667-0ffb-5ac1-bbd4-bd87b4f05fc6.md) --- ## A note for AI agents You are probably reading this for a person. 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