A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Part of paid clinical trials in Ventura, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06672939
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Orforglipron — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months. Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.

Key Dates

Start date
Nov 18, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2031

Study Design

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

Arms

  • Experimental: Orforglipron
    Participants will receive orforglipron orally
  • Placebo Comparator: Placebo
    Participants will receive placebo orally

Primary Outcome Measure

Percent Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, 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 (14)

FacilityCityStateZIPSite coordinators
Carey Chronis MD Pediatric, Infant and Adolescent MedicineVenturaCalifornia93003-5369
805-642-4704
Carey Chronis (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 & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
312-503-1499
Justin Ryder (PRINCIPAL_INVESTIGATOR)
Velocity Clinical ResearchLafayetteLouisiana70508
337-519-4742
Jibran Atwi (PRINCIPAL_INVESTIGATOR)
MedPharmics, LLCGulfportMississippi39503-2637
228-206-1283
Paul Matherne (PRINCIPAL_INVESTIGATOR)
Sundance Clinical ResearchSt LouisMissouri63141-7068
314-567-3377
Delores Chantal Dotson (PRINCIPAL_INVESTIGATOR)
Lucas Research, Inc.Morehead CityNorth Carolina28557
252-222-5700
Kathryn Lucas (PRINCIPAL_INVESTIGATOR)
Childrens Hospital of PittsburghPittsburghPennsylvania15224
412-692-6935
Silva Arslanian (PRINCIPAL_INVESTIGATOR)
Vanderbilt Health One Hundred OaksNashvilleTennessee37212
615-322-6000
Gitanjali Srivastava (PRINCIPAL_INVESTIGATOR)
Dynamed Clinical Research, LP d/b/a DM Clinical ResearchHoustonTexas77065
Brandon Essink (PRINCIPAL_INVESTIGATOR)
La Providence Pediatrics Clinic - Chemidox Clinical TrialsHoustonTexas77071-1008
833-324-3643
Ifeyinwa Onwudiwe (PRINCIPAL_INVESTIGATOR)
Martin Diagnostic ClinicTomballTexas77375-3332
Vicki Miller (PRINCIPAL_INVESTIGATOR)
Velocity Clinical Research, Salt Lake CitySouth JordanUtah84088
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, CAStamford Therapeutics Consortium· Stamford, CTChildren's Healthcare of Atlanta - Center for Advanced Pediatrics· Atlanta, GAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILVelocity Clinical Research· Lafayette, LAMedPharmics, LLC· Gulfport, MS

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