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Study on Maintaining Weight Loss in Teens with Obesity Using Semaglutide

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying obesity in teenagers. The treatment being tested is a medication called semaglutide, which is given as an injection under the skin using a pre-filled pen. The study aims to see how well semaglutide helps teenagers who have lost weight to maintain their weight loss over time. The medication is also known by its code name, NNC0113-0217, and is available in different doses, including 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg.

The purpose of the study is to investigate how effective semaglutide is in helping adolescents maintain a healthy weight after they have already achieved a body mass index (BMI) below the obesity threshold. Participants will receive the treatment for a period of up to six years, with the main focus on maintaining their weight loss from 1.5 years to 3 years. The study will also look at how the dose of semaglutide can be gradually reduced over time.

Throughout the study, participants will be monitored for changes in their BMI, waist circumference, and other health markers such as blood sugar levels and cholesterol. The study will also track any side effects or serious adverse events that may occur. The goal is to provide valuable information on the long-term use of semaglutide in managing obesity in teenagers.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The initial treatment phase involves the administration of semaglutide through a subcutaneous injection. This phase lasts for 1.5 years.

    During this period, the goal is to achieve a Body Mass Index (BMI) below the obesity threshold. The dosage of semaglutide is gradually increased according to a specific schedule.

  2. Step 2

    Dose-tapering phase

    After the initial 1.5 years, the dose-tapering phase begins. This phase continues for another 1.5 years.

    The dosage of semaglutide is gradually reduced to zero. The aim is to maintain the BMI below the obesity threshold during this period.

  3. Step 3

    Continued treatment phase

    The continued treatment phase extends from 3 years up to 6 years.

    The focus is on maintaining the improved BMI category and monitoring various health parameters such as waist circumference, blood pressure, and blood sugar levels.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor changes in BMI, waist-to-height ratio, and other health indicators.

    These assessments help in evaluating the effectiveness of the treatment and making necessary adjustments.

Who can join the trial?

4 criteria

  • The participant and their parent(s) or legally acceptable representative must agree to join the study by signing a form called the Informed Consent Form. This form explains the study and what it involves. The participant must also agree by signing a Child Assent Form or giving verbal agreement, depending on local rules.
  • The participant must be between the ages of 12 and less than 15 years old when they sign the informed consent.
  • The participant's Body Mass Index (BMI) must be at or above the 95th percentile for their age and sex. BMI is a measure that uses height and weight to estimate body fat.
  • The participant must weigh more than 60 kilograms at the time of screening.

Who cannot join the trial?

5 criteria

  • Individuals who have not achieved a Body Mass Index (BMI) below the obesity threshold after 1.5 years of initial treatment cannot participate. BMI is a measure that uses height and weight to estimate body fat.
  • Participants who are not currently receiving treatment with the study medication, semaglutide, are excluded. Semaglutide is a medication used to help manage weight.
  • Individuals who are not adolescents, meaning they are not in the age range specified for the study, cannot participate.
  • Participants who are not willing or able to follow the study's dose-tapering plan are excluded. A dose-tapering plan involves gradually adjusting the amount of medication taken.
  • Individuals with medical conditions or situations that the study team believes could interfere with the study's results or the participant's safety are excluded.
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Investigated drugs

Semaglutide is a medication used in this clinical trial to help adolescents maintain weight loss after they have achieved a body mass index (BMI) below the obesity threshold. It is administered once a week through an injection under the skin. The trial aims to see how effective semaglutide is in helping these adolescents keep the weight off over a long period.

What is already known about the treatment

Semaglutide – This medication is administered as a subcutaneous injection, typically given once a week. It is currently being studied for its effectiveness in maintaining weight loss in adolescents with obesity, following an initial treatment period. Semaglutide is primarily used to help manage obesity by mimicking a hormone that targets areas of the brain involved in regulating appetite and food intake. It belongs to a class of drugs known as GLP-1 receptor agonists, which work by enhancing insulin secretion and reducing appetite.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. The condition develops gradually over time, often due to a combination of genetic, behavioral, and environmental factors. As obesity progresses, it can lead to increased risk of various health issues, such as heart disease, diabetes, and joint problems. The progression of obesity can also affect metabolic functions, leading to changes in blood pressure, cholesterol levels, and insulin sensitivity. Managing obesity often involves lifestyle changes, including diet and physical activity adjustments.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-508055-40-00Protocol codeNN9536-7752Estimated enrolment515 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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