STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

Part of paid clinical trials in Escondido, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT06571383
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Participants will receive semaglutide s.c(under the skin) once weekly.

Study Details

The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.

Key Dates

Start date
Sep 17, 2024
Status verified
Jun 2026
Primary completion
Nov 15, 2028
Completion
Nov 15, 2031

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly

Primary Outcome Measure

Maintenance of Body Mass Index (BMI) below obesity threshold [ Time Frame: From 1.5 years to 3 years ]

Locations (26)

FacilityCityStateZIPSite coordinators
Neighborhood HealthcareEscondidoCalifornia92025-
Clinical Neuroscience SolutionOrlandoFlorida32801-
TMH Physician Partners EndoTallahasseeFlorida32308-
Children's Healthcare AtlantaAtlantaGeorgia30329-
Columbus Research FoundationColumbusGeorgia31904-
Eastside Bariatric and Gen SurgSnellvilleGeorgia30078-
Solaris Clinical ResearchMeridianIdaho83646-
Synexus Clinical Research US Inc.-ChicagoChicagoIllinois60602-
Indiana University HospitalIndianapolisIndiana46505-
University Of Iowa Hospitals and ClinicsIowa CityIowa52242-
Pennington Biom Res CtrBaton RougeLouisiana70808-
Barry J. Reiner, MD LLCBaltimoreMaryland21229-
University of MinnesotaMinneapolisMinnesota55414-
Mississippi CTR for ADV MEDMadisonMississippi39110-
UBMD Peds-Div of Endo/DiabetesBuffaloNew York14203-
WakeMed Childn Endo-Dbt_RaleigRaleighNorth Carolina27610-
Valley Weight Loss ClinicFargoNorth Dakota58104-
Centricity Research - OhioColumbusOhio43213-
PriMed Clinical ResearchDaytonOhio45429-
UPMC Child Hosp-PittsburghPittsburghPennsylvania15224-
Coastal Carolina Research CtrNorth CharlestonSouth Carolina29405-
Clinical Neuroscience SolutionsMemphisTennessee38119-
Clinical Trials of Texas IncSan AntonioTexas78229-
Texas Diabetes InstituteSan AntonioTexas78207-5209-
Health Res of Hampton RoadsNewport NewsVirginia23606-
Virginia Commonwealth UnivRichmondVirginia23298-

Find similar trials in Escondido, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Neighborhood Healthcare· Escondido, CAClinical Neuroscience Solution· Orlando, FLTMH Physician Partners Endo· Tallahassee, FLChildren's Healthcare Atlanta· Atlanta, GAColumbus Research Foundation· Columbus, GAEastside Bariatric and Gen Surg· Snellville, GA

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