Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07759245

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Médico Viamonte, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brenipatide

Drug

Brenipatide administered SC

Other names: LY3537031

Placebo

Drug

Placebo administered SC

Standard of care

Drug

SOC

Primary outcomes

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

    Time frame: Baseline through Week 36

Secondary outcomes

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

    Time frame: Baseline through Week 52

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

    Time frame: Baseline, Week 36, and Week 52

  3. Change from Baseline in Pre-BD FEV₁

    Time frame: Baseline through Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: RENEW-COPD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.