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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT07759245
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Brenipatide — DRUG
    Brenipatide administered SC
  • Placebo — DRUG
    Placebo administered SC
  • Standard of Care — DRUG
    SOC

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
606 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
484-707-6813
Surya Bhatt (PRINCIPAL_INVESTIGATOR)
NewportNativeMD, Inc.Newport BeachCalifornia92663
949-791-8599
Ryan Klein (PRINCIPAL_INVESTIGATOR)
Institute of HealthCare Assessment d/b/a Apex Clinical ResearchSan DiegoCalifornia92120
619-582-5564
Edward Federman (PRINCIPAL_INVESTIGATOR)
National Jewish Health Medical CenterDenverColorado80206
Michael Wechsler (PRINCIPAL_INVESTIGATOR)
Millennium Medical Research - MiamiMiamiFlorida33126
David Orta (PRINCIPAL_INVESTIGATOR)
Deluxe Health CenterMiami LakesFlorida33014
305-209-1268
Raiko Diaz (PRINCIPAL_INVESTIGATOR)
Florida Institute For Clinical Research, LLCOrlandoFlorida32825
407-658-0966
Humberto Cruz (PRINCIPAL_INVESTIGATOR)
Axis Clinical Trials - WestchesterWestchesterIllinois60154
Mohammad Ghani (PRINCIPAL_INVESTIGATOR)
Indiana University Health University HospitalIndianapolisIndiana46202
317-278-0099
Cynthia Brown (PRINCIPAL_INVESTIGATOR)
IU Health Ball Memorial Hospital, Inc.MuncieIndiana47303
Sashank Kolli (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
617-732-8201
Carrie Pistenmaa (PRINCIPAL_INVESTIGATOR)
Revive Research Institute, Inc.SouthfieldMichigan48075
248-829-3103
Syed Raza (PRINCIPAL_INVESTIGATOR)
Headlands Research-Twin CitiesMaplewoodMinnesota55109
Charlene McEvoy (PRINCIPAL_INVESTIGATOR)
Clinical Research Associates of Central PADuBoisPennsylvania15801
814-940-1212
Sandeep Bansal (PRINCIPAL_INVESTIGATOR)
Premier Pulmonary Critical Care and SleepDenisonTexas75020
469-714-9864
Sanober Kable (PRINCIPAL_INVESTIGATOR)
Baylor College of Medicine Medical CenterHoustonTexas77030
NICOLA HANANIA (PRINCIPAL_INVESTIGATOR)
Prime Clinical Research - LewisvilleLewisvilleTexas75067
817-907-7330
Adekunle Adekola (PRINCIPAL_INVESTIGATOR)
Paramount Clinical Research - Data Point Clinical ResearchKirklandWashington98034
425-577-1107
Javier Nazar (PRINCIPAL_INVESTIGATOR)

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