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NCT Number: NCT05726227

A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.

The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinik Kinder-Jugendheilkunde Innsbruck, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, 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. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
  • Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1
  • Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)
  • History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months
  • Body weight of greater than 45 kilogram (kg) at screening and randomisation
  • For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening

Exclusion criteria

  • 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: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening
  • Type 1 diabetes mellitus or monogenic diabetes
  • Participants with endocrine, hypothalamic, or syndromic obesity
  • For participants with T2D at screening, the following additional key criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Treatment and study plan

semaglutide

Drug

Semaglutide will be administered subcutaneously once weekly.

Placebo

Drug

Placebo will be administered subcutaneously once-weekly.

Primary outcomes

  1. Group Kids: Change in body mass index (BMI)

    Time frame: From baseline (week 0) to week 68

    Measured in percentage (%)

Secondary outcomes

  1. Group Kids: Improvement in weight category

    Time frame: From baseline (week 0) to week 68

    Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.

  2. Group Teens: Change in BMI

    Time frame: From week 0 to week 68

    Measured in %

  3. Group Kids and Group Teens: Change in BMI

    Time frame: From week 0 to week 104

    Measured in %

  4. Group Teens: Improvement in weight category

    Time frame: From week 0 to week 68

    Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.

  5. Group Kids and Group Teens: Improvement in weight category

    Time frame: From week 0 to week 104

    Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.

  6. Group Kids and Group Teens: Change in body weight

    Time frame: From week 0 to week 68

    Measured in percentage

  7. Group Kids and Group Teens: Change in body weight

    Time frame: From week 0 to week 104

    Measured in percentage

  8. Group Kids and Group Teens: Change in body weight

    Time frame: From week 0 to week 68

    Measured in kilograms (kg)

  9. Group Kids and Group Teens: Change in body weight

    Time frame: From week 0 to week 104

    Measured in kilograms (kg)

  10. Group Kids and Group Teens: Change in BMI percentage of the 95th percentile

    Time frame: From week 0 to week 68

    Measured in percentage points

  11. Group Kids and Group Teens: Change in BMI percentage of the 95th percentile

    Time frame: From week 0 to week 104

    Measured in percentage points

  12. Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)

    Time frame: From week 0 to week 68

    Measured as score on a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.

  13. Group Kids and Group Teens: Change in BMI SDS

    Time frame: From week 0 to week 104

    Measured as score in a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.

  14. Group Kids and Group Teens: Change in waist circumference

    Time frame: From week 0 to week 68

    Measured in centimeters (cm)

  15. Group Kids and Group Teens: Change in waist circumference

    Time frame: From week 0 to week 104

    Measured in centimeters (cm)

  16. Group Kids and Group Teens: Change in systolic blood pressure

    Time frame: From week 0 to week 68

    Measured in millimeters of mercury (mmHg)

  17. Group Kids and Group Teens: Change in systolic blood pressure

    Time frame: From week 0 to week 104

    Measured in millimeters of mercury (mmHg)

  18. Group Kids and Group Teens: Change in diastolic blood pressure

    Time frame: From week 0 to week 68

    Measured in mmHg

  19. Group Kids and Group Teens: Change in diastolic blood pressure

    Time frame: From week 0 to week 104

    Measured in mmHg

  20. Group Kids and Group Teens: Change in total cholesterol

    Time frame: From week 0 to week 68

    Measured in %

  21. Group Kids and Group Teens: Change in total cholesterol

    Time frame: From week 0 to week 104

    Measured in %

  22. Group Kids and Group Teens: Change in high density lipoprotein (HDL)

    Time frame: From week 0 to week 68

    Measured in %

  23. Group Kids and Group Teens: Change in high density lipoprotein (HDL)

    Time frame: From week 0 to week 104

    Measured in %

  24. Group Kids and Group Teens: Change in low density lipoprotein (LDL)

    Time frame: From week 0 to week 68

    Measured in %

  25. Group Kids and Group Teens: Change in low density lipoprotein (LDL)

    Time frame: From week 0 to week 104

    Measured in %

  26. Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)

    Time frame: From week 0 to week 68

    Measured in %

  27. Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)

    Time frame: From week 0 to week 104

    Measured in %

  28. Group Kids and Group Teens: Change in triglycerides

    Time frame: From week 0 to week 68

    Measured in %

  29. Group Kids and Group Teens: Change in triglycerides

    Time frame: From week 0 to week 104

    Measured in %

  30. Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)

    Time frame: From week 0 to week 68

    Measured in %

  31. Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)

    Time frame: From week 0 to week 104

    Measured in %

  32. Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)

    Time frame: From week 0 to week 68

    Measured in % point

  33. Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)

    Time frame: From week 0 to week 104

    Measured in % point

  34. Group Kids and Group Teens: Change in fasting plasma glucose

    Time frame: From week 0 to week 68

    Measured in millimoles per liter (mmol/L)

  35. Group Kids and Group Teens: Change in fasting plasma glucose

    Time frame: From week 0 to week 104

    Measured in millimoles per liter (mmol/L)

  36. Group Kids and Group Teens: Change in fasting plasma glucose

    Time frame: From week 0 to week 68

    Measured in milligrams per deciliter (mg/dL)

  37. Group Kids and Group Teens: Change in fasting plasma glucose

    Time frame: From week 0 to week 104

    Measured in milligrams per deciliter (mg/dL)

  38. Group Kids and Group Teens: Change in fasting insulin

    Time frame: From week 0 to week 68

    Measured in %

  39. Group Kids and Group Teens: Change in fasting insulin

    Time frame: From week 0 to week 104

    Measured in %

  40. Group Kids and Group Teens: Change in alanine transaminase (ALT)

    Time frame: From week 0 to week 68

    Measured in milliunits per liter (mU/L)

  41. Group Kids and Group Teens: Change in alanine transaminase (ALT)

    Time frame: From week 0 to week 104

    Measured in milliunits per liter (mU/L)

  42. Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass

    Time frame: From week 0 to week 68

    Measured in % points

  43. Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass

    Time frame: From week 0 to week 104

    Measured in % points

  44. Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass

    Time frame: From week 0 to week 68

    Measured in % points

  45. Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass

    Time frame: From week 0 to week 104

    Measured in % points

  46. Group Kids and Group Teens: Relative change in visceral fat mass by DXA

    Time frame: From week 0 to week 68

    Measured in %

  47. Group Kids and Group Teens: Relative change in visceral fat mass by DXA

    Time frame: From week 0 to week 104

    Measured in %

  48. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)

    Time frame: From week 0 to week 68

    Measured in count of participants

  49. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)

    Time frame: From week 0 to week 104

    Measured in count of participants

  50. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)

    Time frame: From week 0 to week 68

    Measured in count of participants

  51. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)

    Time frame: From week 0 to week 104

    Measured in count of participants

  52. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)

    Time frame: From week 0 to week 68

    Measured in count of participants

  53. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)

    Time frame: From week 0 to week 104

    Measured in count of participants

  54. Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)

    Time frame: From week 0 to week 68

    Measured as count of events

  55. Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)

    Time frame: From week 0 to week 111

    Measured as count of events

  56. Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)

    Time frame: From week 0 to week 68

    Measured as count of events

  57. Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)

    Time frame: From week 0 to week 111

    Measured as count of events

  58. Group Kids and Group Teens: Change in pulse

    Time frame: From week 0 to week 68

    Measured as beats per minute

  59. Group Kids and Group Teens: Change in pulse

    Time frame: From week 0 to week 104

    Measured as beats per minute

  60. Group Kids and Group Teens: Change in amylase

    Time frame: From week 0 to week 68

    Measured as units per liter (U/L)

  61. Group Kids and Group Teens: Change in amylase

    Time frame: From week 0 to week 104

    Measured as units per liter (U/L)

  62. Group Kids and Group Teens: Change in lipase

    Time frame: From week 0 to week 68

    Measured as U/L

  63. Group Kids and Group Teens: Change in lipase

    Time frame: From week 0 to week 104

    Measured as U/L

  64. Group Kids and Group Teens: Change in calcitonin

    Time frame: From week 0 to week 68

    Measured as nanograms per liter (ng/L)

  65. Group Kids and Group Teens: Change in calcitonin

    Time frame: From week 0 to week 104

    Measured as nanograms per liter (ng/L)

  66. Group Kids and Group Teens: Change in bone mineral density, by DXA

    Time frame: From week 0 to week 68

    Measured as grams per square centimeter (g/cm^2)

  67. Group Kids and Group Teens: Change in bone mineral density, by DXA

    Time frame: From week 0 to week 104

    Measured as grams per square centimeter (g/cm^2)

  68. Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)

    Time frame: From week 0 to week 68

    Measured as count of episodes

  69. Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)

    Time frame: From week 0 to week 111

    Measured as count of episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Long-term Safety and Efficacy of Semaglutide s.c. Once-weekly on Weight Management in Children and Adolescents (Aged 6 to <18 Years) With Obesity or Overweight

Acronym: STEP Young

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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