A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06439277
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Key Dates

Start date
Jun 3, 2024
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Tirzepatide
    Participants will receive tirzepatide subcutaneously (SC).
  • Placebo Comparator: Placebo
    Participants will receive placebo SC.

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 (15)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Sutter Valley Medical Foundation (SVMF) Pediatric EndocrinologySacramentoCalifornia95821-
Nemours Children's Health - DelawareWilmingtonDelaware19803-
CenExel iResearch, LLCDecaturGeorgia30030
404-537-1281
Kimball Johnson (PRINCIPAL_INVESTIGATOR)
Medical Research PartnersAmmonIdaho83406-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Indiana University Health University HospitalIndianapolisIndiana46202-
UBMD PediatricsBuffaloNew York14203-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Driscoll Children's HospitalCorpus ChristiTexas78411-
Epic Medical Research - DeSotoDeSotoTexas75115-
Valley Institute of Research - Fort WorthFort WorthTexas76164-
Consano Clinical Research, LLCShavano ParkTexas78231-
Texas Valley Clinical ResearchWeslacoTexas78596-
Alliance for Multispecialty Research, LLCLaytonUtah84041-

Find similar trials in Los Angeles, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital Los Angeles· Los Angeles, CASutter Valley Medical Foundation (SVMF) Pediatric Endocrinology· Sacramento, CANemours Children's Health - Delaware· Wilmington, DECenExel iResearch, LLC· Decatur, GAMedical Research Partners· Ammon, IDAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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