Craniopharyngioma
Conditions
Interventions
Semaglutide once weekly in increasing dosis, versus placebo, for ~1year.
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with craniopharyngioma, aged =16 years; • BMI =30 kg/m2; • No surgical intervention for craniopharyngioma one year before inclusion; • Adequate hormone replacement therapy (with or without growth hormone) in the past 4 weeks.
Exclusion criteria
Exclusion criteria: • Pregnancy (wish); • Breastfeeding or plan to breastfeed during treatment; • Allergy or oversensitivity for GLP-1 analogues or components; • Multiple Endocrine Neoplasia syndrome 2 (MEN2 syndrome); • Up to second degree family members with medullary thyroid carcinoma; • Gastroparesis or severe digestive problems; • History of or current pancreatitis; • Amylase or lipase above 2 times the upper normal range; • Active gallbladder disease; • Current depression or suicidal thoughts; • Liver failure; • Renal impairment measured by Glomerular Filtration Rate (GFR) value less than 30 ml/min/1,73 m6 (less than 60 ml/min/1,73 m^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors); • NYHA class IV heart failure; • Insulin-dependent diabetes mellitus; • Use of another GLP-1 analogue; • Succeeded bariatric surgery (=10% weight loss); • Extreme fear of needles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight and metabolic related: - Change in BMI at end of follow-up (approximately 1 year after treatment is stopped); - Proportion of patients who achieve BMI maintenance (defined as less than 5% change in BMI or 1 SDS - Change in weight (kg) at end of treatment and last follow-up - Change in body fat percentage as measured by Dual X-ray Absorptiometry; - Obesity rates after 54 weeks of treatment and at end of follow-up (obesity is defined as BMI =30 kg/m2) (53) - Change in (systolic and diastolic) blood pressure - Presence of diabetes mellitus - Presence of cardiovascular disease - The Metabolic Syndrome and its components after end of treatment and after 2 years of follow-up (the Metabolic Syndrome is defined according to the IDF consensus, with 3/5 criteria for obesity, high triglycerides, low HDL-cholesterol, hypertension and hyperglycaemia) (54) Quality of life related: - Change in physical functioning score (Short Form 36) and its subcomponents - Health related quality of life by EQ5D-5L Safety related: - Number of and reason for discontinuation and lack adherence of treatment/placebo - Number of (serious) adverse events (with distinction grade 3-4 adverse events and relation to the treatment) Efficacy related: - Number of and reason for discontinuation and lack adherence of treatment/placebo - (genetic) differences between responders and non-responders) | — |
Contacts
Public ContactSelvetta van Santen
Erasmus MC, Rotterdam, the Netherlands
Outcome results
None listed