Genentech, a member of the Roche Group, disclosed favorable outcomes from the Phase Ib clinical trial of CT-388, a dual GLP-1/GIP receptor agonist aimed at addressing obesity and type 2 diabetes. The study revealed that administering CT-388 through a once-weekly subcutaneous injection over 24 weeks resulted in significant weight reduction in healthy adults with obesity compared to a placebo. Notably, CT-388 achieved a clinically significant mean placebo-adjusted weight loss of 18.8% (p-value < 0.001). By week 24, all participants treated with CT-388 experienced weight loss surpassing 5%, with 85% achieving over 10%, 70% over 15%, and 45% over 20%. The treatment demonstrated favorable tolerability, with mild to moderate gastrointestinal-related adverse events being the most common, consistent with the medication’s class.
Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development, expressed satisfaction with the noteworthy weight loss observed in individuals undergoing CT-388 treatment. He emphasized the promising implications for CT-388’s continued development in combating both obesity and type 2 diabetes, highlighting its potential as a leading therapy offering enduring weight loss and glucose control.
Given the escalating global obesity crisis, with its myriad associated health complications, including type 2 diabetes, cardiovascular ailments, steatohepatitis, and chronic kidney disease, CT-388 emerges as a promising intervention. With an estimated four billion people projected to be affected by obesity or overweight by 2035, innovative treatments like CT-388 are crucial for alleviating the strain on healthcare systems worldwide.
CT-388 operates within the class of incretin-based medications, targeting blood sugar regulation and appetite suppression. By selectively activating GLP-1 and GIP receptors, CT-388 orchestrates nutrient-derived signals to regulate food intake, energy absorption, and assimilation. Its unique dual-targeting mechanism holds promise for sustained glucose reduction and weight loss, alongside a favorable safety profile.
Further exploration of CT-388’s efficacy in obese patients with type 2 diabetes is underway in an ongoing placebo-controlled Phase Ib trial. Data from this additional cohort are anticipated in the latter half of 2024.
About the CT-388 Study: The CT-388-101 trial is a comprehensive Phase Ib study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CT-388 in healthy adults with overweight or obesity, as well as those with obesity and type 2 diabetes mellitus. The trial’s primary endpoint is CT-388’s safety and tolerability, with secondary endpoints encompassing its impact on body weight and glucose homeostasis. Additionally, the trial assesses CT-388’s pharmacokinetics and other pharmacodynamic effects.
About CT-388: CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist designed for obesity and type 2 diabetes treatment. Engineered for potent activity on both GLP-1 and GIP receptors while minimizing ß-arrestin recruitment, CT-388 aims to prolong pharmacological activity by reducing receptor internalization and desensitization. It is currently undergoing investigation in a multi-part, multi-cohort Phase 1 clinical trial involving individuals with overweight/obesity, with and without type 2 diabetes.