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

Novo Nordisk

Status and phase: Begins enrollment this month; Phase 4

Conditions: Obesity

Treatments: Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571383

2023-508055-40 (Other Identifier)

U1111-1295-4799 (Other Identifier)

NN9536-7752

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 12 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Semaglutide

Experimental group

Description:

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

Treatment:

Drug: Semaglutide