Authorised Therapeutic confirmatory (Phase III) Obesity and overweight

STEP Young: A research study on how well semaglutide helps children and teenagers with excess body weight lose weight

EU CTIS ID: 2022-502922-41-00

What this study is testing

Group Kids: To confirm superiority of semaglutide s.c. once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity on weight management in children with obesity (ages 6 to <12 years).

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, 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 parent(s) 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, of: a. Group Kids: 6 to < 12 years, b. Group Teens: 12 to < 18 years, and Tanner stage > 1
BMI, at screening and randomisation, corresponding to a. Group Kids: ≥95th percentile, b. Group Teens: ≥95th percentile or ≥85th percentilea with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or 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 (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
Body weight of >45 kg at screening and randomisation.
[For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:] Treatment with either lifestyle intervention, or treatment with metformin according to local label. Treatment with metformin should be stable (same drug(s), dose, and dosing frequency) for at least 90 days before screening

You likely can't join if

[Obesity related] Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
[Additional mental health for Group Teens] A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening
[Additional mental health for Group Teens] Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 30 days before screening
[General Safety] History or presence of chronic pancreatitis (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[General Safety] Presence of acute pancreatitis within 180 days before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[General Safety] Calcitonin ≥50 ng/L

See the full eligibility criteria

Who can join

Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, 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 parent(s) 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, of: a. Group Kids: 6 to < 12 years, b. Group Teens: 12 to < 18 years, and Tanner stage > 1
BMI, at screening and randomisation, corresponding to a. Group Kids: ≥95th percentile, b. Group Teens: ≥95th percentile or ≥85th percentilea with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or 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 (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
Body weight of >45 kg at screening and randomisation.
[For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:] Treatment with either lifestyle intervention, or treatment with metformin according to local label. Treatment with metformin should be stable (same drug(s), dose, and dosing frequency) for at least 90 days before screening
[For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:] HbA1c ≤10.0% (86 mmol/mol) as measured by central laboratory at screening
[For participants assessed by DXA scan the following additional criteria must apply]: Evaluation of the quality of the DXA scan must be performed and found acceptable by the imaging laboratory prior to randomisation
[For participants assessed by DXA scan the following additional criteria must apply]: BMI ≤ 40.0 kg/m2 at screening

What rules you out

[Obesity related] Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
[Additional mental health for Group Teens] A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening
[Additional mental health for Group Teens] Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 30 days before screening
[General Safety] History or presence of chronic pancreatitis (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[General Safety] Presence of acute pancreatitis within 180 days before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[General Safety] Calcitonin ≥50 ng/L
[General Safety] Personal, or first-degree relative’s, history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[General Safety] Type 1 diabetes mellitus or monogenic diabetes
[General Safety] Renal impairment with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2, as calculated by the Bedside Schwartz equation (According to the current version of National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, National Institutes of Health) and Kidney Disease Improving Global Outcomes (KDIGO) pediatric clinical practice guidelines)
[General Safety] Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[General Safety] Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator
[Obesity related] 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 >1 year prior to screening, (2) adjustable gastric banding, if the band has been removed >1 year prior to screening, (3) intragastric balloon, if the balloon has been removed >1 year prior to screening or (4) duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year prior to screening.
[General Safety] Known or suspected abuse of alcohol or recreational drugs
[General Safety] Use of any medication with unknown or unspecified content within 90 days before screening
[General Safety] Known or suspected hypersensitivity to study product(s) or related products
[General Safety] Previous participation in this study. Participation is defined as signed informed consent
[General Safety] Participation (i.e., signed informed consent) in any interventional, clinical study of an approved or non-approved investigational medicinal product within 90 days before screening
[General Safety] Other participant(s) from the same household participating in any semaglutide study
[General Safety] Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG) within 180 days before screening, new clinically significant arrhythmias or conduction delays on ECG identified at screening
[General Safety] Female who is pregnant, breast feeding, intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method, as defined in Appendix 4, Section ‎10.4
[General Safety] Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the participant’s safety or compliance with the protocol
[Glycaemia-related] Treatment with glucose-lowering agent(s) within 90 days before screening (except for metformin)
[Obesity related] Uncontrolled thyroid disease
[Glycaemia-related] Treatment with a GLP-1 receptor agonist within 180 days before screening
[Diabetes related for participants with T2D] 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
[Diabetes related for participants with T2D] Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies
[Obesity related] Participants with endocrine, hypothalamic, or syndromic obesity
[Obesity related] A self-reported (or by parent(s)/LAR where applicable) change in body weight >5% within 90 days before screening irrespective of medical record
[Mental health] History of major depressive disorder within 2 years before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[Mental health] Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) [As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records]
[Mental health] A lifetime history of suicidal attempt (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
[Mental health] Suicidal behaviour within 30 days before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
Mexico
Israel
United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Mexico; Israel; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.