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

Objective: Pharmacokinetic (PK) similarity between biosimilar candidate LRG201902 and European Union-sourced liraglutide reference product (Victoza(R)) was evaluated. Safety and immunogenicity were also assessed. Methods: 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(R) 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(0-t), AUC(0-infinity), and C-max. Pharmacokinetic similarity was achieved if 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0-t, AUC(0-infinity), and C-max were within the range of 80-125%. Other pharmacokinetic parameters including T-max, t(1/2), and lambda(z) were also measured. Safety profile and immunogenicity data were collected from each subject. Results: C-max, AUC(0-t), and AUC(0-infinity) were similar between the two groups. GMRs of Cmax, AUC(0-t), and AUC(0-infinity) were 113.50%, 107.21%, and 106.97% between LRG201902 and Victoza(R) respectively. The 90% CIs for the GMRs of C-max, AUC(0-t), and AUC(0-infinity) were all within the PK equivalence criteria. Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T-max, t(1/2), and lambda(z)) were comparable between groups. Treatment-related adverse events were reported by 27.8% and 23.7% subjects in the LRG201902 and Victoza(R) arms, respectively. All post-dose samples were detected negative for anti-drug antibodies. Conclusion: This study demonstrates pharmacokinetic similarity of LRG201902 to Victoza(R) in healthy subjects. The safety and immunogenicity profiles were similar for the two products.

Automated summary

The study demonstrated pharmacokinetic similarity between LRG201902 and Victoza(R) in healthy subjects, with comparable safety and immunogenicity profiles in the two products.