RENEW-COPD

RecruitingPhase 2

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

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)

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

127

Recruiting sites

Estimated enrollment

606

Study population

Pulmonary Disease, Chronic Obstructive

Eligibility highlights

Primary endpoint

•Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07759245

Org study ID27825

Secondary ID2026-525480-41-00

Secondary IDJ2S-MC-GZMVEli Lilly and Company

Timeline

Milestones

Study start2026-08-07actual

Study first posted2026-08-12actual

Last update posted2026-11-05actual

Primary completion2028-05estimated (month precision)

Study completion2028-11estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Pulmonary Disease, Chronic Obstructive

Who can enroll

Minimum age40 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score

Time frame:Baseline, Week 36, and Week 52

change from baseline, improvement

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Baseline through Week 36

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment

Time frame:Baseline through Week 52

descriptive

Secondary/protocol endpoint/low confidence

Change from Baseline in Pre-BD FEV₁

Time frame:Baseline through Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.