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

Phase 4Active Not RecruitingNCT06571383

Novo Nordisk A/S500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Obesity

Interventions

SemaglutideDRUG

Participants will receive semaglutide s.c(under the skin) once weekly.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study: 1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements 2. The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements * Age 12 to less than 15 years at the time of signing the informed consent * BMI greater than or equal to 95th percentile at screening * Body weight greater than 60 kg at screening Exclusion criteria: * Prepubertal status (Tanner stage 1) * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: 1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening 2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening 3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening 4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening * Endocrine, hypothalamic, or syndromic obesity * History of type 1 or type 2 diabetes mellitus

Locations (93)

Outcomes

Primary Outcomes

Maintenance of Body Mass Index (BMI) below obesity threshold

Measures as count of participants

Time frame: From 1.5 years to 3 years

Secondary Outcomes

Maintenance of improved Body Mass Index (BMI) category

Measured as count of participants

Time frame: From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

Tapering to zero dose

Measured as count of participants

Time frame: From 1.5 years to 3 years

Time/dose steps before ending dose tapering

Measured in weeks, count of dose steps

Time frame: From 1.5 years to 3 years

Achieving Body Mass Index (BMI) below obesity threshold

Measured as count of participants

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Achieving any improvement in Body Mass Index (BMI) category

Measured as count of participants

Time frame: From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)

Change in Body Mass Index (BMI)

Measured in percentage (%)

Time frame: From baseline (day 0) to 1.5 and 3 years

Body Mass Index (BMI) percentage of the 95th percentile

Measured in percentage (%)

Data from ClinicalTrials.gov

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Time frame: From baseline (day 0) to 1.5 and 3 years

Change in Body Mass Index Standard Deviation Score (BMI SDS)

Unitless

Time frame: From baseline (day 0) to 1.5 and 3 years

Change in waist-to-height ratio (waist [cm]/ height [cm])

Unitless

Time frame: From baseline (day 0) to 1.5 and 3 years

Change in waist circumference

Measured in centimeters (cm)

Time frame: From baseline (day 0) to 1.5 and 3 years

Change in HbA1c

Measured in percentage (%) points

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Change in fasting plasma glucose

Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL)

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Measured in percentage (%)

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Change in high sensitivity C-reactive protein (hsCRP)

Measured in percentage (%)

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides

Measured in percentage (%)

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Change in systolic and diastolic blood pressure

Measured in millimetres of mercury (mmHg)

Time frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass

Measured in percentage (%) points

Time frame: From baseline (day 0) to 1.5 and 3 years

Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass

Measured in percentage (%) points

Time frame: From baseline (day 0) to 1.5 and 3 years

Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)

Measured in percentage (%)

Time frame: From baseline (day 0) to 1.5 and 3 years

Serious Adverse Event (SAE)

Count

Time frame: 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)