Liraglutide (RD12014) pharmacokinetic and safety similarity to Victoza® evaluated in healthy Chinese subjects

The global burden of Type 2 Diabetes Mellitus (T2DM) necessitates effective and accessible treatment options. Liraglutide, a glucagon-like peptide-1 receptor (GLP-1R) agonist, is a well-established therapy for T2DM, known for its glucose-lowering effects and cardiovascular benefits. As patents expire, the development of biosimilar or bioequivalent formulations is crucial to increase patient access and reduce healthcare costs. This study addresses the need to confirm that new generic versions of liraglutide, such as RD12014, maintain comparable pharmacokinetic profiles, safety, and immunogenicity to the innovator product, Victoza®, ensuring therapeutic equivalence.

This randomized, single-dose, Phase 1 study compared liraglutide injection (RD12014) from Sunshine Lake Pharma with liraglutide injection (Victoza®) from Novo Nordisk. A total of 28 healthy male Chinese subjects were enrolled. The primary objective was to evaluate the pharmacokinetic similarity between the two formulations after a single dose. Secondary objectives included assessing the similarity of safety and immunogenicity profiles. The study design was randomized, with subjects receiving either RD12014 or Victoza®. Pharmacokinetic parameters such as Cmax (maximum plasma concentration) and AUC (area under the curve) were likely measured, alongside monitoring for adverse events and anti-drug antibodies to assess safety and immunogenicity.

The abstract primarily outlines the study's objectives rather than presenting specific numerical results. The core aim was to evaluate the pharmacokinetic similarity of RD12014 to Victoza® following a single dose in healthy male subjects. This evaluation typically involves comparing key pharmacokinetic parameters like Cmax and AUC to determine if they fall within predefined bioequivalence limits (e.g., 80-125% ratio of geometric means). The study also aimed to assess the similarity of the safety profiles, looking for comparable incidence and severity of adverse events between the two formulations. Furthermore, the immunogenicity of RD12014 and Victoza® was to be compared, which involves measuring the development of anti-drug antibodies. While specific data points are not provided, the completion status and design suggest these evaluations were performed.

The primary objective was to evaluate the pharmacokinetic similarity between the liraglutide injection (RD12014) and Victoza® for single dose in healthy male subjects.