OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.

Korábbi kezelés

• Treatment with any medication for the indication of obesity within the past 90 days before screening
• 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
• Treatment with a GLP-1 receptor agonist within 180 days before screening
• 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)
• 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

Más betegség

• Type 1 diabetes
• Type 2 diabetes
• Uncontrolled thyroid disease at screening, in the opinion of the investigator
• 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 of malignant neoplasms within the past 5 years prior to the day of screening
• Known history of, or documented positive hepatitis B or C or HIV infection
• 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
• Participants with confirmed diagnosis of bulimia nervosa disorder

Laborértékek

• 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
• 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
• Treatment with glucose-lowering agent(s) within 90 days before screening (except for metformin)
• 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

Egyéb

• Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
• Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
• History or presence of pancreatitis (acute or chronic)
• Female who is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)

• 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