See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 9-17 years old
* Body Mass Index Z-score ≥ 4 SD of French reference
* Weight at enrolment ≥ 50 kg
* Therapeutic failure \> 6 months
* For girls of childbearing age, willing to have an acceptable method of contraception (no estrogens plus progestin)
* Negative pregnancy test for girls of childbearing age
* Agreeing to participate upon written informed consent
* Appropriate understanding of the study
Exclusion Criteria:
* Syndromic or secondary obesity
* Major neurological or psychiatric disorder
* Current or history of suicidal thought/attempts
* Current or history of breakdown
* Previous bariatric surgery
* Severe hypercapnia
* Renal dysfunction
* Deformity in the urinary tract or solitary kidney
* History of renal lithiasis or glaucoma
* Poorly controlled diabetic children or adolescents (HbA1c \>10%) and diabetic patients treated with Metformine and/or glibenclamide
* Hepatic dysfunction
* Bicarbonate ≤16 mmol/L
* Known hypersensitivity to the active substance or to one of the excipients
* Intolerance to saccharose
* Enrolment in another therapeutic study
* High probability to fail to comply with treatment
* Females: Pregnant, planning to become pregnant
* No signature on consent form
* Uncovered by the French National health Insurance system (Sécurité sociale)