Chugai Pharmaceutical Co., Ltd. announced on October 10, 2025, that it has secured exclusive Japanese development and marketing rights for CT-388, a promising dual GLP-1/GIP receptor agonist from Roche, marking a significant expansion of obesity and diabetes treatment options in Japan. The licensing agreement positions Chugai to bring this innovative therapy to Japanese patients while Roche receives upfront fees and milestone payments.
Impressive Phase I Clinical Results
CT-388 demonstrated remarkable efficacy in its overseas Phase I clinical study (CT-388-101 trial), where adults with obesity received weekly subcutaneous injections for 24 weeks. The trial results showed a placebo-adjusted mean weight reduction of -18.8% (p<0.001) at week 24, representing clinically meaningful and statistically significant weight loss compared to placebo.
The weight reduction outcomes were particularly striking across different thresholds: 100% of participants in the CT-388 treatment group achieved greater than 5% weight reduction, while 85% achieved greater than 10%, 70% achieved greater than 15%, and 45% achieved greater than 20% weight reduction. These results suggest CT-388 may offer superior weight management compared to existing therapies.
Dual Mechanism of Action
CT-388 selectively acts on both GLP-1 and GIP receptors, a dual mechanism that is expected to provide sustained weight reduction and improved glycemic control. This approach represents an advancement in incretin-based therapy design, potentially offering enhanced therapeutic benefits for patients with obesity or type 2 diabetes.
"CT-388 selectively acts on both GLP-1 and GIP receptors. It is expected to provide sustained weight reduction and good glycemic control, offering a potential new treatment option for patients with obesity or type 2 diabetes," said Dr. Osamu Okuda, Chugai's President and CEO.
Safety Profile and Development Progress
The treatment demonstrated a favorable safety profile, with mostly mild to moderate gastrointestinal side effects commonly observed with incretin-based therapies. This tolerability profile aligns with the known safety characteristics of the incretin drug class, suggesting CT-388 may be well-accepted by patients.
CT-388 is currently advancing through Phase II clinical trials overseas for obesity with type 2 diabetes, indicating continued development momentum. Chugai has committed to working closely with Roche to accelerate CT-388's development and deliver the therapy to Japanese patients as quickly as possible.
Strategic Partnership
The licensing agreement leverages the established partnership between Chugai and the Roche Group, allowing Chugai to utilize Roche's research and development resources to identify innovative treatments for unmet medical needs. This collaboration model has proven successful for both companies in bringing novel therapies to market.
