A phase 1, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of KN056 (a recombinant human GLP-1 variant Fc fusion protein) in healthy Chinese participants

May 6, 2025Expert opinion on investigational drugs

Safety, body effects, and processing of the new GLP-1 protein KN056 in healthy Chinese adults

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Abstract

KN056 exposure increased proportionally with dose, with a half-life ranging from 141 to 188 hours.

  • A maximum reduction of 29.9% in glucose levels was observed at 72 hours post-dosing in the oral glucose tolerance test.
  • Gastrointestinal adverse events were the most common side effects, particularly at the highest dose of 12.0 mg.
  • Body weight decreased by an average of -1.68 kg in the 12.0 mg group within seven days, though no significant change was noted by the end of the study.
  • KN056 demonstrated favorable pharmacokinetics and pharmacodynamics in healthy Chinese participants.

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