Family-powered lifestyle overhaul put to the test against childhood obesity

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged 10 to 16 years * Tanner stage 1-5 pubertal development at the time of signing informed consent * ISO-BMI ≥30kg/m2 * History of failing to lose sufficient weight with lifestyle modification as judged by the Exclusion Criteria: * Treatment with any medication for the indication of obesity within the past 90 days before screening * Type 1 diabetes * Type 2 diabetes * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes) * Uncontrolled thyroid disease at screening, in the opinion of the investigator * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes) * History of major depressive disorder within 2 years before screening * Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) * A lifetime history of suicidal attempt * Subjects with confirmed diagnosis of bulimia nervosa disorder * History or presence of pancreatitis (acute or chronic) * Impaired renal function defined as serum-creatinine \>UNR for age in children unless renal function is proven normal by further assessments at the discretion of the investigator * History of malignant neoplasms within the past 5 years prior to the day of screening * Any medical condition or laboratory abnormality, including any clinically significant out-of-range vital signs, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate för the study * Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator * Known or suspected abuse of alcohol or recreational drugs * Previous participation in this trial. Participation is defined as signed informed consent * Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening * Female who is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) * Treatment with glucose-lowering agent(s) within 90 days before screening (except for metformin) * Treatment with a GLP-1 receptor agonist within 180 days before screening * Known history of, or documented positive hepatitis B or C or HIV infection * Aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 x upper-limit of normal * Creatinine clearance (CrCl) \< 60 ml/min measured by 24-hour urine collection or estimated from the Cockcroft and Gault formula * Clinically significant ECG findings as judged by the investigator ((including history of clinically significant arrhythmias or conduction delays on electrocardiogram \[ECG\]) within 180 days before screening, new clinically significant arrhythmias, or conduction delays on ECG identified at screening) * Known history of other heart diseases * History of major depressive disorder within 2 years before screening * Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) * A lifetime history of suicidal attempt * Suicidal behavior within 30 days before screening * Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening * Participants with confirmed diagnosis of bulimia nervosa disorder