A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT04102189
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
  • Placebo — OTHER
    Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks

Study Details

This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.

Key Dates

Start date
Oct 7, 2019
Status verified
Dec 2025
Primary completion
Mar 25, 2022
Completion
Mar 28, 2022

Study Design

Enrollment
201 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in Body Mass Index (BMI) (Percentage [%]) [ Time Frame: Baseline (week 0), week 68 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles - EndocrinologyLos AngelesCalifornia90027-
Solaris Clinical ResearchMeridianIdaho83646-
Pennington Biomed Res CtrBaton RougeLouisiana70808-4124-
DelRicht ResearchGretnaLouisiana70053-
Barry J. Reiner, MD LLCBaltimoreMaryland21229-
Massachusetts General Hospital_CaryBostonMassachusetts02114-2621-
University of Minnesota_CPOMMinneapolisMinnesota55414-
University of Minnesota_MinneapolisMinneapolisMinnesota55455-
UBMD Peds-Div of Endo/DiabetesBuffaloNew York14203-
WakeMed Childn Endo-Dbt_RaleigRaleighNorth Carolina27610-
Valley Weight Loss ClinicFargoNorth Dakota58104-
Aventiv Research IncColumbusOhio43213-
PriMed Clinical ResearchDaytonOhio45419-
Geisinger ClinicDanvillePennsylvania17822-2111-
Children's Hosptl PhiladelphiaPhiladelphiaPennsylvania19104-
UPMC Child Hosp-PittsburghPittsburghPennsylvania15224-
Medical Research South, LLC_CaryGoose CreekSouth Carolina29445-
Greenville Hospital System Pediatric EndoGreenvilleSouth Carolina29615-
Monument Health Clinical RsrchRapid CitySouth Dakota57701-
Discovery MM Services, IncHoustonTexas77061-
Univ Of Texas Hlth Science CntrSan AntonioTexas78229-
National Clin Res Inc.RichmondVirginia23294-
Marshfield ClinicMarshfieldWisconsin54449-

Find similar trials in Los Angeles, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital Los Angeles - Endocrinology· Los Angeles, CASolaris Clinical Research· Meridian, IDPennington Biomed Res Ctr· Baton Rouge, LADelRicht Research· Gretna, LABarry J. Reiner, MD LLC· Baltimore, MDMassachusetts General Hospital_Cary· Boston, MA

Related Studies