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

Part of paid clinical trials in Tucson, Arizona.

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

First listed
Nov 4, 2024
Start date
Nov 18, 2024
Status verified
Jul 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 (51)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85721
Sunil Sinha (PRINCIPAL_INVESTIGATOR)
Loma Linda University School of MedicineLoma LindaCalifornia92354
Prashanth Porayette (PRINCIPAL_INVESTIGATOR)
Childrens Hospital of Los AngelesLos AngelesCalifornia90027
Alaina Vidmar (PRINCIPAL_INVESTIGATOR)
UCLA Mattel Children's HospitalLos AngelesCalifornia90095
Vibha Singhal (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Orange County - OrangeOrangeCalifornia92868
Amruta Thakkar (PRINCIPAL_INVESTIGATOR)
Carey Chronis MD Pediatric, Infant and Adolescent MedicineVenturaCalifornia93003-5369
805-642-4704
Carey Chronis (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoColorado SpringsColorado80920-7843
Melanie Cree (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)
William A. Shands Hospital at the University of FloridaGainesvilleFlorida32610-3003
Angelina Bernier (PRINCIPAL_INVESTIGATOR)
Florida Hospital- Center for Pediatric ResearchOrlandoFlorida32803
Konda Reddy (PRINCIPAL_INVESTIGATOR)
Nemours Children's HealthOrlandoFlorida32827
Miles Yu (PRINCIPAL_INVESTIGATOR)
All Childrens HospitalSt. PetersburgFlorida33701
Raquel Hernandez (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)
University of Illinois at ChicagoChicagoIllinois60612
Shruti Sakhuja (PRINCIPAL_INVESTIGATOR)
Riley Hospital for ChildrenIndianapolisIndiana46202
Sara Naramore (PRINCIPAL_INVESTIGATOR)
Norton Children's EndocrinologyLouisvilleKentucky40202
Sara Watson (PRINCIPAL_INVESTIGATOR)
Velocity Clinical ResearchLafayetteLouisiana70508
337-519-4742
Jibran Atwi (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Children's CenterBaltimoreMaryland21287
Gihan Naguib (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Amy Fleischman (PRINCIPAL_INVESTIGATOR)
Helen Devos Childrens' Hospital - PINGrand RapidsMichigan49503-2560
Miriam Vos (PRINCIPAL_INVESTIGATOR)
University of Minnesota Masonic Children's HospitalMinneapolisMinnesota55454
Claudia Fox (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - PINRochesterMinnesota55905-0001
Seema Kumar (PRINCIPAL_INVESTIGATOR)
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes CenterSaint PaulMinnesota55102-3354
Jennifer Abuzzahab (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)
Omaha Childrens HospitalOmahaNebraska68114
Alvaro Flores Lopez (PRINCIPAL_INVESTIGATOR)
Velocity Clinical ResearchOmahaNebraska68134
402-933-6500
Brandon Essink (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Steven Ghanny (PRINCIPAL_INVESTIGATOR)
UBMD PediatricsBuffaloNew York14203
Lucy Mastrandrea (PRINCIPAL_INVESTIGATOR)
UNC Children's HospitalChapel HillNorth Carolina27514
Nina Jain (PRINCIPAL_INVESTIGATOR)
Duke Children's Primary CareDurhamNorth Carolina27704-2102
Sarah Armstrong (PRINCIPAL_INVESTIGATOR)
Lucas Research, IncMorehead CityNorth Carolina28557
252-222-5700
Kathryn Lucas (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Roy Kim (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Joan Han (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Jeanie Tryggestad (PRINCIPAL_INVESTIGATOR)
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
412-692-6935
Silva Arslanian (PRINCIPAL_INVESTIGATOR)
Coastal Pediatric AssociatesCharlestonSouth Carolina29414
Stephen Stripling (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina Children Hospital - PINCharlestonSouth Carolina29425
Christine San Giovanni (PRINCIPAL_INVESTIGATOR)
Vanderbilt Health One Hundred OaksNashvilleTennessee37204
615-322-6000
Gitanjali Srivastava (PRINCIPAL_INVESTIGATOR)
Dell Children's Medical Center - PINAustinTexas78723-3079
Gunjan Dokania (PRINCIPAL_INVESTIGATOR)
Driscoll Children's HospitalCorpus ChristiTexas78411
Ana Paez (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)
McGovern Medical SchoolHoustonTexas77030-1521
Mona Eissa (PRINCIPAL_INVESTIGATOR)
Martin Diagnostic ClinicTomballTexas77375-3332
281-517-0550
Helen Shpats (PRINCIPAL_INVESTIGATOR)
Velocity Clinical Research, Salt Lake CityWest JordanUtah84088
801-542-8190
Barbara Rizzardi (PRINCIPAL_INVESTIGATOR)
VCU Health - Center for Endocrinology Diabetes and MetabolismRichmondVirginia23229-3156
Edmond Wickham (PRINCIPAL_INVESTIGATOR)
Seattle Children's Research Institute - Hughes Building - PINSeattleWashington98101
Kalie Tommerdale (PRINCIPAL_INVESTIGATOR)
MultiCare Health System - Mary Bridge Children's Health CenterTacomaWashington98405
Bhuvana Sunil (PRINCIPAL_INVESTIGATOR)

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By research site
University of Arizona· Tucson, AZLoma Linda University School of Medicine· Loma Linda, CAChildrens Hospital of Los Angeles· Los Angeles, CAUCLA Mattel Children's Hospital· Los Angeles, CAChildren's Hospital of Orange County - Orange· Orange, CACarey Chronis MD Pediatric, Infant and Adolescent Medicine· Ventura, CA

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