Recruiting
Phase 2

Brenipatide

Sponsor:

Eli Lilly and Company

Code:

NCT07759245

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Brenipatide

Placebo

Standard of Care

Study Details

Brief summary:

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT07759245

Start date

Aug 7, 2026

Status verified date

Sep, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not 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.

Study Design

Enrollment

606 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brenipatide Dose 1

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

experimental: Brenipatide Dose 2

Brenipatide high dose administered SC in combination with SOC.

placebo comparator: Placebo

Placebo administered SC in combination with SOC.

Interventions

Brenipatide

Brenipatide administered SC

Placebo

Placebo administered SC

Standard of Care

SOC

Primary outcome measure

  • Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁) [ Time Frame: Baseline through Week 36 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

NewportNativeMD, Inc.

Recruiting

Newport Beach, California, United States, 92663

Contacts

949-791-8599

Principal Investigator:

Ryan Klein

Institute of HealthCare Assessment d/b/a Apex Clinical Research

Recruiting

San Diego, California, United States, 92120

Contacts

619-582-5564

Principal Investigator:

Edward Federman

Millennium Medical Research - Miami

Recruiting

Miami, Florida, United States, 33126

Principal Investigator:

David Orta

Deluxe Health Center

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

305-209-1268

Principal Investigator:

Raiko Diaz

Florida Institute For Clinical Research, LLC

Recruiting

Orlando, Florida, United States, 32825

Contacts

407-658-0966

Principal Investigator:

Humberto Cruz

Axis Clinical Trials - Westchester

Recruiting

Westchester, Illinois, United States, 60154

Principal Investigator:

Mohammad Ghani

IU Health Ball Memorial Hospital, Inc.

Recruiting

Muncie, Indiana, United States, 47303

Principal Investigator:

Sashank Kolli

Revive Research Institute, Inc.

Recruiting

Southfield, Michigan, United States, 48075

Contacts

248-829-3103

Principal Investigator:

Syed Raza

Headlands Research-Twin Cities

Recruiting

Maplewood, Minnesota, United States, 55109

Principal Investigator:

Charlene McEvoy

Clinical Research Associates of Central PA

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

814-940-1212

Principal Investigator:

Sandeep Bansal

Prime Clinical Research - Lewisville

Recruiting

Lewisville, Texas, United States, 75067

Contacts

817-907-7330

Principal Investigator:

Adekunle Adekola

Paramount Clinical Research - Data Point Clinical Research

Recruiting

Kirkland, Washington, United States, 98034

Contacts

425-577-1107

Principal Investigator:

Javier Nazar

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Emphysema
  • Chronic Bronchitis
  • Lung Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.