Semaglutide is a glucagon-like peptide-1 analogue (GLP-1) approved for once-weekly (OW) subcutaneous treatment of type 2 diabetes (Ozempic®). This randomised, double-blind, placebo-controlled, 13-week trial assessed the pharmacokinetics, safety and tolerability of OW semaglutide in healthy male and female Chinese subjects. A total of 36 subjects were randomised to 0.5 mg (n=12) or 1.0 mg (n=12) OW semaglutide, or corresponding volumes of placebo (n=12). The primary endpoint was steady-state semaglutide exposure (AUC0 168h [area under the curve over a dosing interval]). Semaglutide exposure at steady state (see Figure) was consistent with dose-proportionality. Treatment ratios (1.0 mg/0.5 mg) were: AUC0-168h: 1.99, and Cmax: 1.94. Accumulation was consistent with the half-life (∼1 week). In this trial, treatment with OW semaglutide was well tolerated, consistent with the GLP-1 class. The PK profile in Chinese subjects was consistent with previous trials. The most common adverse events were gastrointestinal events. NCT03288740.
A. Shi: None. P. Xie: None. L.L. Nielsen: None. T.V. Skjoeth: Employee; Self; Novo Nordisk A/S. X. He: None. S.P. Haugaard: Employee; Self; Novo Nordisk A/S.
Novo Nordisk A/S