Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice

Korábbi kezelés

• The safety and efficacy of Wegovy have not been investigated in patients:
  • treated with other products for weight management,
  • with type 1 diabetes,
  • with severe renal impairment (see section 4.2),
  • with severe hepatic impairment (see section 4.2),
  • with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended

Laborértékek

• Hypersensitivity to the active substance or to any of the excipients listed:
  • Disodium phosphate, dihydrate
  • Propylene glycol
  • Phenol
  • Hydrochloric acid (for pH adjustment)
  • Sodium hydroxide (for pH adjustment)
  • Water for injection

Egyéb

• Participation in any interventional clinical trials at the time of enrolment.
• Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)

• Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
• Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate.
• Age at time of signing informed consent: ≥12 to \<21 years.
• BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)
• Body weight of \>60 kg.
• Diagnosis of monogenic obesity by a Clinical Laboratory Improvement Amendments (CLIA)/ College of American Pathologists (CAP)/International Organisation for Standardization (ISO) 1518-certified laboratory using ACMG criteria as pathogenic (P), likely pathogenic (LP) and variant of uncertain significance (VUS).