Cytoki Pharma Doses First Patient in Phase 2 Trial of CK-0045 for Obesity and Type 2 Diabetes

Cytoki Pharma, a clinical-stage biotech firm specialising in innovative IL-22-based therapies for metabolic conditions, announced that the first patient has been dosed with CK-0045 in a Phase 2 proof-of-concept trial. This study will assess CK-0045’s effectiveness, safety, and tolerability in patients dealing with obesity and type 2 diabetes. CK-0045, an IL-22 analogue, uses advanced lipidation technology to prolong its circulation in the body, making subcutaneous delivery feasible and positioning it as a pioneering option for managing obesity and type 2 diabetes.

Phase 1 trial results for CK-0045 in healthy volunteers have shown promising outcomes, with successful target engagement and dose-dependent reductions in body weight, as well as improvements in LDL cholesterol, blood insulin, and insulin resistance. With a strong safety profile, these findings encourage the continued clinical development of CK-0045. In the next step, a 16-week, randomised, double-blind, placebo-controlled Phase 2 study (NCT06611930) will test the effectiveness, safety, and tolerability of two CK-0045 doses. The trial will involve 90 patients with obesity and type 2 diabetes, who will receive weekly subcutaneous injections.

The study explores a variety of metabolic advantages associated with IL-22 modulation, including weight reduction, alterations in HbA1c levels, assessments of insulin sensitivity, and changes in lipid profiles. Results are expected to be released in the first half of 2026. Furthermore, Cytoki is actively developing a comprehensive portfolio of IL-22-based therapies aimed at addressing significant unmet needs in metabolic disorders and inflammatory bowel disease.

Anne Louise Kjølbye, Ph.D., MBA, CDO at Cytoki, said in a statement, "A leading public health priority, obesity and diabetes cumulatively impact more than one billion individuals worldwide. While the emergence of incretin-based medicines has provided new treatment options, there remains a demand for novel approaches that offer additional cardiometabolic benefits beyond body weight reduction alone. CK-0045 offers a novel approach to metabolic disease treatment with the potential to prolong healthy lifespan through muscle-sparing weight loss accompanied by broader health benefits.”

Dr Carel le Roux, Professor of Experimental Pathology, University College Dublin, stated, "Encouraging results from the Phase 1 study of CK-0045 demonstrate the potential of its unique IL-22 based mechanism of action as a powerful new therapeutic approach to address obesity and type 2 diabetes. We eagerly anticipate Cytoki's progress as it continues clinical evaluation of CK-0045 and develops its broader IL-22-derived pipeline to deliver novel treatments for metabolic disease."