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

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: Brenipatide; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT07759245

27825

J2S-MC-GZMV (Other Identifier)

2026-525480-41-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 606 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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606 participants in 3 patient groups, including a placebo group

Brenipatide Dose 1

Experimental group

Description:

Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).

Treatment:

Drug: Standard of Care

Drug: Brenipatide

Brenipatide Dose 2

Experimental group

Description:

Brenipatide high dose administered SC in combination with SOC.

Treatment:

Drug: Standard of Care

Drug: Brenipatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC in combination with SOC.

Treatment:

Drug: Standard of Care

Drug: Placebo