肾功能或肝功能损害不影响皮下注射卡格里林肽的药代动力学、安全性和耐受性.pdf

1、Renal or hepatic impairment does not affect the pharmacokinetics,safety or tolerability of subcutaneous cagrilintideMette J.F.Nielsen1,Niels-Peter Becker1,Helene H.Hansen Duus1,Katrine Kirkeby1,Viera Kupov2,Britt W.Lauenborg1,Benjamin Low1,Olivia Svolgaard1,Louise Witten1PO4.267https:/ QR code or vi

2、sit the website below for:PosterPoster+slidesAim The aim of these two clinical pharmacology studies was:To investigate the pharmacokinetics(PK),safety and tolerability following administration of a single subcutaneous dose of cagrilintide in participants with renal or hepatic impairment compared wit

3、h participants with normal renal or hepatic function(NCT04209049 and NCT05564104,respectively).To determine if cagrilintide dosages need to be adjusted in people with impaired renal or hepatic function.Introduction Cagrilintide is a long-acting amylin receptor agonist in development as a monotherapy

4、 for the treatment of overweight and obesity,and as a fixed-dose combination with the glucagon-like peptide-1 receptor agonist semaglutide(CagriSema)for weight management and the treatment of type 2 diabetes.13 Cagrilintide efficacy,safety,and tolerability have been assessed in several completed and

5、 ongoing phase 3 clinical studies which have included more than 1000 participants.1,2 Regulatory authorities advise assessing how renal and hepatic impairment affects the PK of new drugs,as this evaluation may indicate the need for dose adjustment in these populations.47 As chronic kidney disease an

6、d liver disease(including metabolic dysfunction-associated steatotic liver disease)are common comorbidities of obesity,understanding the effects of renal or hepatic impairment on the PK of cagrilintide is crucial.47Methods Male and female participants of non-childbearing potential aged 1880 years wi