A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Part of paid clinical trials in Orange, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07286175
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Brenipatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Key Dates

Start date
Nov 24, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Brenipatide Dose 1
    Brenipatide administered subcutaneous (SC) + SoC.
  • Experimental: Brenipatide Dose 2 .
    Brenipatide administered subcutaneous (SC) + SoC.
  • Placebo Comparator: Placebo
    Placebo administered SC + SoC.

Primary Outcome Measure

Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion [ Time Frame: Randomization up to at least 6 months ]

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 (20)

FacilityCityStateZIPSite coordinators
ATP Clinical ResearchOrangeCalifornia92866
949-354-5353
Gustavo Alva (PRINCIPAL_INVESTIGATOR)
Yale University School of MedicineNew HavenConnecticut06519
203-932-5711
Mohini Ranganathan (PRINCIPAL_INVESTIGATOR)
AGA Clinical TrialsHialeahFlorida33012
3058196990 X 1
WILSON CUEVA (PRINCIPAL_INVESTIGATOR)
Accel Research Sites - Maitland Clinical Research UnitMaitlandFlorida32751
386-785-2400
Andrea Marraffino (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - MaitlandMaitlandFlorida32751
Sejal Patel (PRINCIPAL_INVESTIGATOR)
Floridian Clinical Research, LLCMiami LakesFlorida33016-1518
305-330-9977
Hortensia Valeron (PRINCIPAL_INVESTIGATOR)
CLA ResearchNaplesFlorida34116
239-837-8818
Evelia Iglesias (PRINCIPAL_INVESTIGATOR)
Charter Research - OrlandoOrlandoFlorida32803
Jorel Martinez (PRINCIPAL_INVESTIGATOR)
Encore Medical Research - WestonWestonFlorida33331
954-777-8827
Luis Marchany Alfonso (PRINCIPAL_INVESTIGATOR)
Atlanta Center for Medical ResearchAtlantaGeorgia30331
Elyssa Barron (PRINCIPAL_INVESTIGATOR)
Covenant Medical CenterWaterlooIowa50702
319-272-2112
NICHOLAS GOETSCH (PRINCIPAL_INVESTIGATOR)
CBH HealthGaithersburgMaryland20877
301-251-4702
Elia Acevedo Diaz (PRINCIPAL_INVESTIGATOR)
Elixia MASpringfieldMassachusetts01103
413-305-1142
Susan Smiga (PRINCIPAL_INVESTIGATOR)
Adams Clinical WatertownWatertownMassachusetts02472
617-744-8542
Dyanna Domilici (PRINCIPAL_INVESTIGATOR)
Penn Medicine: University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104
yvette sheline (PRINCIPAL_INVESTIGATOR)
Revival Research Institute, LLCMcKinneyTexas75071
Jawad Riaz (PRINCIPAL_INVESTIGATOR)
Pillar Clinical Research - RichardsonRichardsonTexas75080
214-396-4844
Scott Bartley (PRINCIPAL_INVESTIGATOR)
Alpine Research OrganizationClintonUtah84015
801-928-3292
Michael Roundy (PRINCIPAL_INVESTIGATOR)
Re:Cognition HealthFairfaxVirginia22031
Scott Williams (PRINCIPAL_INVESTIGATOR)
Northwest Clinical Research CenterBellevueWashington98007
425-453-0404
Wisam Al jumaili (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By condition
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By specialty
PsychiatryMental healthBehavioral health
By research site
ATP Clinical Research· Orange, CAYale University School of Medicine· New Haven, CTAGA Clinical Trials· Hialeah, FLAccel Research Sites - Maitland Clinical Research Unit· Maitland, FLK2 Medical Research - Maitland· Maitland, FLFloridian Clinical Research, LLC· Miami Lakes, FL

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