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

Phase 1

• Conditions: Obesity and overweight; MedDRA version: 20.0Level: PTClassification code: 10033307Term: Overweight Class: 100000004861; MedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2022-502922-41-00
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

Exclusion Criteria

[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 preg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified