A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Part of paid clinical trials in Ventura, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06672549
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Orforglipron — DRUG
    Administered orally. ISA specific interventions will be listed in the ISA.
  • Placebo — DRUG
    Administered orally. ISA specific interventions will be listed in the ISA.

Study Details

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Key Dates

Start date
Nov 18, 2024
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Orforglipron (ISA PW01)
    Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.

Primary Outcome Measure

Number of Participants Allocated to Each ISA [ Time Frame: Baseline to Week 72 ]

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 (16)

FacilityCityStateZIPSite coordinators
Carey Chronis MD Pediatric, Infant and Adolescent MedicineVenturaCalifornia93003-5369
805-642-4704
Carey Chronis (PRINCIPAL_INVESTIGATOR)
Yale School of Medicine - Yale Diabetes Center (YDC)) TrialsNew HavenConnecticut06519
Ania Jastreboff (PRINCIPAL_INVESTIGATOR)
Stamford Therapeutics ConsortiumStamfordConnecticut06905
727-544-4842
David Radin (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of Atlanta - Center for Advanced PediatricsAtlantaGeorgia30329
404-712-4731
Daniel Hsia (PRINCIPAL_INVESTIGATOR)
Ann and Robert Lurie Children's Hospital of ChicagoChicagoIllinois60611
312-503-1499
Justin Ryder (PRINCIPAL_INVESTIGATOR)
Velocity Clinical ResearchLafayetteLouisiana70508
337-519-4742
Jibran Atwi (PRINCIPAL_INVESTIGATOR)
Dynamed Clinical Research, LP d/b/a DM Clinical ResearchGulfportMississippi39503-2637
228-206-1283
Paul Matherne (PRINCIPAL_INVESTIGATOR)
Sundance Clinical ResearchSt LouisMissouri63141-7068
314-567-3377
Delores Chantal Dotson (PRINCIPAL_INVESTIGATOR)
Velocity Clinical ResearchOmahaNebraska68134
402-933-6500
Brandon Essink (PRINCIPAL_INVESTIGATOR)
Lucas Research, IncMorehead CityNorth Carolina28557
252-222-5700
Kathryn Lucas (PRINCIPAL_INVESTIGATOR)
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
412-692-6935
Silva Arslanian (PRINCIPAL_INVESTIGATOR)
Vanderbilt Health One Hundred OaksNashvilleTennessee37204
615-322-6000
Gitanjali Srivastava (PRINCIPAL_INVESTIGATOR)
Dynamed Clinical Research, LP d/b/a DM Clinical ResearchHoustonTexas77065
281-517-0550
Kashif Ali (PRINCIPAL_INVESTIGATOR)
La Providence Pediatrics Clinic - Chemidox Clinical TrialsHoustonTexas77071-1008
833-324-3643
Ifeyinwa Onwudiwe (PRINCIPAL_INVESTIGATOR)
Martin Diagnostic ClinicTomballTexas77375-3332
281-517-0550
Vicki Miller (PRINCIPAL_INVESTIGATOR)
Velocity Clinical Research, Salt Lake CityWest JordanUtah84088
801-542-8190
Barbara Rizzardi (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ventura, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Carey Chronis MD Pediatric, Infant and Adolescent Medicine· Ventura, CAYale School of Medicine - Yale Diabetes Center (YDC)) Trials· New Haven, CTStamford Therapeutics Consortium· Stamford, CTChildren's Healthcare of Atlanta - Center for Advanced Pediatrics· Atlanta, GAAnn and Robert Lurie Children's Hospital of Chicago· Chicago, ILVelocity Clinical Research· Lafayette, LA

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