Claire Falandry, Justine Bacchetta, Muriel Doret-Dion, Carole Ferraro-Peyret, Cyrille B Confavreux, Marion Douplat, Patrick Feugier, Arnaud Friggeri, Pierre-Adrien Bolze, Yesim Dargaud, Alexandre Messager, Martine Wallon, Loïc Geffroy, Yves Matillon, Jacques Bradwejn
Tailoring a specific medical leadership development program for faculty members: the Lyon-Ottawa experience
Medical education online
hypothalamic obesity resulting hypothalamic damage might affect melanocortin signalling investigated melanocortin4 receptor agonist setmelanotide treatment hypothalamic obesity phase 2 openlabel multicentre trial done five centres usa eligible patients aged 6 40 years obesity history hypothalamic injury diagnosis nonmalignant tumour affecting hypothalamus treated surgery chemotherapy radiation setmelanotide titrated dose 30 mg administered subcutaneously day total duration 16 weeks primary endpoint proportion patients reduction bmi least 5 baseline 16 weeks compared historic control rate less 5 population primary endpoint analysed using full analysis set includes patients baseline data received least one dose setmelanotide safety assessed patients received least one dose study drug trial registered clinicaltrialsgov nct04725240 complete june 6 2021 jan 13 2022 19 patients screened inclusion one patient excluded 18 enrolled received least one dose setmelanotide patients primarily white n14 78 male n11 61 enrolled patients mean age 150 years sd 53 mean bmi 380 kgm2 sd 65 18 patients enrolled 16 89 18 patients completed study met primary endpoint reduction bmi least 5 baseline 16 weeks p00001 mean reduction bmi across patients 15 sd 10 composite proportion patients clinically meaningful change 89 90 ci 6998 p00001 comprising reduction bmi z score least 02 points patients younger 18 years 92 68100 p00001 reduction bodyweight least 5 patients aged 18 years older 80 3499 p00001 patients aged 12 years older mean reduction hunger score 45 frequent adverse events included nausea 61 vomiting 33 skin hyperpigmentation 33 diarrhoea 22 14 patients continued treatment longterm extension study nct03651765 12 completed least 12 months treatment time publication mean change bmi 26 sd 12 index trial baseline findings support setmelanotide novel effective treatment hypothalamic obesity rhythm pharmaceuticals