Denmark-based clinical-stage biotechnology company Cytoki Pharma, ApS announced on Monday that it has dosed its first patient with CK-0045 in a Phase two proof-of-concept trial assessing the efficacy, safety and tolerability in individuals with obesity and type two diabetes.

Cytoki Pharma says that CK-0045, an IL-22 analogue, uses commercially proven lipidation technology to extend circulation time in the body, allowing subcutaneous delivery and providing first-in-class potential to deal with obesity and type two diabetes. Results from the Phase one clinical study of CK-0045 in healthy volunteers confirmed target engagement and exposure-dependent reductions in body mass, along with improvements in low-density lipoprotein (LDL) cholesterol, blood insulin levels, and insulin resistance. These results, combined with a favourable safety profile, support further clinical advancement of CK-0045.

The 16-week randomised, double-blind, placebo-controlled Phase two study (NCT06611930) is intended to assess the efficacy, safety and tolerability of two doses of CK-0045, administered subcutaneously once a week, in 90 patients with obesity and type two diabetes. The outcomes investigated in the study reflect the wide range of metabolic benefits of IL-22 modulation and include amongst others weight loss, change in HbA1c, insulin sensitivity measurements, and lipid levels. Results of the study are anticipated in the first half of 2026.