STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
- Registration Number
- NCT06571383
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Semaglutide Semaglutide 2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly
- Primary Outcome Measures
Name Time Method Maintenance of Body Mass Index (BMI) below obesity threshold From 1.5 years to 3 years Measures as count of participants
- Secondary Outcome Measures
Name Time Method Tapering to zero dose From 1.5 years to 3 years Measured as count of participants
Time/dose steps before ending dose tapering From 1.5 years to 3 years Measured in weeks, count of dose steps
Achieving Body Mass Index (BMI) below obesity threshold From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured as count of participants
Achieving any improvement in Body Mass Index (BMI) category From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years) Measured as count of participants
Change in Body Mass Index (BMI) From baseline (day 0) to 1.5 and 3 years Measured in percentage (%)
Body Mass Index (BMI) percentage of the 95th percentile From baseline (day 0) to 1.5 and 3 years Measured in percentage (%)
Change in Body Mass Index Standard Deviation Score (BMI SDS) From baseline (day 0) to 1.5 and 3 years Unitless
Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%)
Maintenance of improved Body Mass Index (BMI) category From 1.5 years to 3 years and end of continued treatment phase (up to 6 years) Measured as count of participants
Change in waist-to-height ratio (waist [cm]/ height [cm]) From baseline (day 0) to 1.5 and 3 years Unitless
Change in waist circumference From baseline (day 0) to 1.5 and 3 years Measured in centimeters (cm)
Change in HbA1c From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%) points
Change in fasting plasma glucose From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL)
Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%)
Change in high sensitivity C-reactive protein (hsCRP) From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%)
Change in systolic and diastolic blood pressure From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in millimetres of mercury (mmHg)
Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass From baseline (day 0) to 1.5 and 3 years Measured in percentage (%) points
Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass From baseline (day 0) to 1.5 and 3 years Measured in percentage (%) points
Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA) From baseline (day 0) to 1.5 and 3 years Measured in percentage (%)
Serious Adverse Event (SAE) From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years) Count
Trial Locations
- Locations (90)
Neighborhood Healthcare
🇺🇸Escondido, California, United States
Clinical Neuroscience Solution
🇺🇸Orlando, Florida, United States
TMH Physician Partners Endo
🇺🇸Tallahassee, Florida, United States
Children's Healthcare Atlanta
🇺🇸Atlanta, Georgia, United States
Columbus Research Foundation
🇺🇸Columbus, Georgia, United States
Eastside Bariatric and Gen Surg
🇺🇸Snellville, Georgia, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Synexus Clinical Research US Inc.-Chicago
🇺🇸Chicago, Illinois, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
University Of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Scroll for more (80 remaining)Neighborhood Healthcare🇺🇸Escondido, California, United States