Brenipatide for Chronic Obstructive Pulmonary Disease

(RENEW-COPD Trial)

Not yet recruiting at 128 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Must be taking: LABA, LAMA, ICS
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with moderate-to-severe COPD, including those with chronic bronchitis or lung overinflation. Participants should be generally stable in their condition and able to follow study procedures.

Inclusion Criteria

I have moderate-to-severe COPD with reduced lung function after using a bronchodilator.
I was diagnosed with COPD at least a year ago.
I have had at least two moderate or one severe flare-up in the past year.
See 3 more

Exclusion Criteria

I have a significant lung disease other than COPD.
I do not have any current or recent active infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brenipatide or placebo administered subcutaneously in combination with Standard of Care for COPD

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares different doses of a new drug called Brenipatide to a placebo, alongside standard care, to see if Brenipatide is safe and effective for people with COPD. The trial lasts about one year.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Brenipatide Dose 2Experimental Treatment2 Interventions
Group II: Brenipatide Dose 1Experimental Treatment2 Interventions
Group III: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University