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

NCT07759245
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Phase
Phase 2
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Recruitment status
Not yet recruiting
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Participants
606
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Lead sponsor
Eli Lilly and Company
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Start date
2026-08-01
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Number of sites
128
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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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Acronym
RENEW-COPD
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Short title
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-11-01
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First posted
2026-08-12
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Registry last updated
2026-08-24
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Primary completion date
2028-05-01
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Start date
2026-08-01
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Participants
606
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Participant count basis
Estimated
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Planned participants
606
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Protocol amendments
0
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Number of sites
128
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07759245
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ClinicalTrials.gov ID
NCT07759245
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)

    Timeframe: Baseline through Week 36

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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
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  • 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
clinicaltrials.gov

  • 2026-525480-41-00
  • J2S-MC-GZMV
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)