A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT07219173
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma. Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.

Key Dates

Start date
Oct 22, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Brenipatide Dose 1
    Brenipatide administered subcutaneously (SC)
  • Experimental: Brenipatide Dose 2
    Brenipatide administered SC.
  • Placebo Comparator: Placebo
    Placebo administered SC.

Primary Outcome Measure

Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment [ Time Frame: Baseline to Week 52 ]

Central Contacts

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

Locations (17)

FacilityCityStateZIPSite coordinators
AMR ClinicalTempeArizona85281
602-910-3343
William Reedy (PRINCIPAL_INVESTIGATOR)
NewportNativeMD, Inc.Newport BeachCalifornia92663
949-791-8599
Ryan Klein (PRINCIPAL_INVESTIGATOR)
California Medical Research AssociatesNorthridgeCalifornia91324
Sanjay Vadgama (PRINCIPAL_INVESTIGATOR)
Peninsula Research AssociatesRolling Hills EstatesCalifornia90274
310-265-1623
Lawrence Sher (PRINCIPAL_INVESTIGATOR)
Asthma & Allergy Associates - Colorado SpringsColorado SpringsColorado80907
Luke Webb (PRINCIPAL_INVESTIGATOR)
AMR ClinicalDoralFlorida33172-2514
Abid Chaudhry (PRINCIPAL_INVESTIGATOR)
Renstar Medical ResearchOcalaFlorida34470
352-629-5800
Raj Karunakara (PRINCIPAL_INVESTIGATOR)
Avanza Medical Research CenterPensacolaFlorida32503
850-477-7900
Linda McCafferty (PRINCIPAL_INVESTIGATOR)
USF HealthTampaFlorida33613
813-631-4024
Thomas Casale (PRINCIPAL_INVESTIGATOR)
Axis Clinical Trials - WestchesterWestchesterIllinois60154
Mohammad Ghani (PRINCIPAL_INVESTIGATOR)
Allergy & Asthma Specialists, P.S.C.OwensboroKentucky42301
270-684-6144
Lee Clore (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Dinah Foer (PRINCIPAL_INVESTIGATOR)
AMR ClinicalLas VegasNevada89119
702-597-9825
Michael Jacobs (PRINCIPAL_INVESTIGATOR)
Equity MedicalNew YorkNew York10455
Alissa McInerney (PRINCIPAL_INVESTIGATOR)
Allergy and Clinical Immunology AssociatesPittsburghPennsylvania15241
412-833-4051
Michael Palumbo (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
630-981-1261
Marc Gauthier (PRINCIPAL_INVESTIGATOR)
Vanderbilt Asthma, Sinus and Allergy ProgramNashvilleTennessee37203
Elizaveta Kalaidina (PRINCIPAL_INVESTIGATOR)

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