A Randomized Phase 1 Pharmacokinetic Study Comparing the Potential Biosimilar LRG201902 With Liraglutide (Victoza ® ) in Healthy Male Subjects

Pharmacokinetic (PK) similarity between biosimilar candidate LRG201902 and European Union-sourced liraglutide reference product (Victoza ) was evaluated. Safety and immunogenicity were also assessed. This single-dose, randomized, open-label, 2-period crossover study (CTR20192342) was conducted in thirty-eight healthy adult male subjects. Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza or LRG201902 by subcutaneous injection during the first period. Following 8 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration. The primary pharmacokinetic endpoints were AUC , AUC , and C . Pharmacokinetic similarity was achieved if 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0-t, AUC , and C were within the range of 80-125%. Other pharmacokinetic parameters including T , t , and λ were also measured. Safety profile and immunogenicity data were collected from each subject. C , AUC , and AUC were similar between the two groups. GMRs of Cmax, AUC , and AUC were 113.50%, 107.21%, and 106.97% between LRG201902 and Victoza respectively. The 90% CIs for the GMRs of C , AUC , and AUC were all within the PK equivalence criteria. Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T , t , and λ ) were comparable between groups. Treatment-related adverse events were reported by 27.8% and 23.7% subjects in the LRG201902 and Victoza arms, respectively. All post-dose samples were detected negative for anti-drug antibodies. This study demonstrates pharmacokinetic similarity of LRG201902 to Victoza in healthy subjects. The safety and immunogenicity profiles were similar for the two products.