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POMC, PCSK1, and LEPR Deficiency and BBS (Pediatric Patients Aged 2 to less than 6 Years) The safety of IMCIVREE was evaluated in one 52-week, open-label clinical trial of 12 patients aged 2 to less than 6 years with obesity due to POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPRgenes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance, or obesity due to BBS (Trial 5) [see Clinical Studies (14.4)]
Abbreviations AMPK: AMP-activated protein kinase CNS: Central nervous system DIO: Diet-induced obesity FGF21: Fibroblast growth factor 21 GCGR: Glucagon receptor GIP: Glucose-dependent insulinotropic polypeptide GLP-1: Glucagon-like peptide 1 K ATP channel: ATP-sensitive potassium channel MBH: Mediobasal hypothalamus NAFLD: Non-alcoholic fatty liver disease PKA: Protein kinase A STZ: Streptozotocin References Banting FG, Best CH, Collip JB, Campbell WR, Fletcher AA (1922) Pancreatic extracts in the treatment of diabetes mellitus
Investigations to date have demonstrated promising safety and efficacy profiles [178]
Volume of Distribution Volume of distribution (V) relates the amount of drug in the body to the concentration of drug (C) in blood or plasma: The volume of distribution may be defined with respect to blood, plasma, or water (unbound drug), depending on the concentration used in equation (1) (C = C b , C p , or C u )
10.1016/j.bbagen.2014.09.024 Biochim Biophys Acta 73
