Health Trials

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

ConditionPulmonary Disease, Chronic Obstructive
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Brenipatide

    Drug

    Brenipatide administered SC

  • Placebo

    Drug

    Placebo administered SC

  • Standard of Care

    Drug

    SOC

Treatment groups

606 Participants
are divided into 3 treatment groups
Group A: Brenipatide Dose 1Experimental treatment 2 interventions
Group B: Brenipatide Dose 2Experimental treatment 2 interventions
Group C: PlaceboPlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: