Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin.

ABSTRACT: This first-in-human study investigated the safety, pharmacokinetics, and pharmacodynamics of the long-acting fibroblast growth factor 21 (FGF21) analog zalfermin. Healthy male participants (n = 56) with body mass index 25.0-34.9 kg/m² were randomized to single ascending doses (2, 6, 12, 24, 48, 96, and 180 mg) of subcutaneous zalfermin or placebo. In a second study, a single dose of 12, 30, or 96 mg was administered to Japanese (n = 24) and non-Asian (n = 18) healthy males to confirm a consistent safety and pharmacokinetic profile across ethnicity. Overall, 98 participants were enrolled across both studies and followed for 36 days. Blood samples were obtained for safety and for pharmacokinetic and pharmacodynamic assessments. The primary endpoint for both studies was the number

SUBMITTER: Dahl K 

PROVIDER: S-EPMC12680786 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature