Cytoki Pharma has announced the dosing of the first patient in its Phase 2 clinical trial evaluating CK-0045 for the treatment of obesity and type 2 diabetes. This randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of CK-0045 in 90 individuals with both conditions. The trial's outcomes will provide insights into the potential of IL-22 modulation for a range of metabolic benefits.
CK-0045: A Novel IL-22 Analogue
CK-0045 is a long-acting analogue of interleukin-22 (IL-22), a cytokine that selectively targets epithelial cells. The drug utilizes lipidation technology to extend its circulation time, allowing for subcutaneous administration. This first-in-class therapy holds promise for addressing metabolic diseases, including obesity and type 2 diabetes, as well as conditions characterized by epithelial injury, such as inflammatory bowel disease. CK-0045 was in-licensed from Novo Nordisk A/S.
Phase 2 Trial Design and Objectives
The Phase 2 study (NCT06611930) is designed as a 16-week trial where participants will receive one of two doses of CK-0045 or a placebo, administered subcutaneously once a week. The primary and secondary endpoints include weight loss, change in HbA1c, insulin sensitivity measurements, and lipid levels. Results from the trial are anticipated in the first half of 2026.
Promising Phase 1 Results
Data from a Phase 1 clinical study of CK-0045 in healthy volunteers (NCT05712876) demonstrated target engagement and exposure-dependent reductions in body mass. The study also reported improvements in low-density lipoprotein (LDL) cholesterol, blood insulin levels, and insulin resistance. These findings, along with a favorable safety profile, support the continued clinical development of CK-0045.
Expert Commentary
"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," said Dr Carel le Roux, Professor of Experimental Pathology, University College Dublin. "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."
The Broader Context of Obesity and Type 2 Diabetes
Obesity and diabetes represent a significant global health challenge, affecting over one billion individuals worldwide. While incretin-based medicines have emerged as valuable treatment options, there remains a need for novel approaches that offer additional cardiometabolic benefits beyond weight loss. Cytoki Pharma aims to address this unmet need with CK-0045, potentially offering muscle-sparing weight loss and broader health benefits.
