Chugai In-Licenses GLP-1/GIP Receptor Agonist CT-388

• Chugai obtained exclusive development and marketing rights in Japan for CT-388, a long-acting GLP-1/GIP receptor agonist under development for obesity and type 2 diabetes, from Roche.
• With its selective action on both GLP-1 and GIP receptors, CT-388 is expected to provide sustained weight reduction and glycemic control with favorable tolerability.

TOKYO, October 10, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has concluded a license agreement with F. Hoffmann-La Roche Ltd (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Thomas Schinecker] for CT-388, a long-acting GLP-1/GIP receptor agonist, currently in development for obesity and type 2 diabetes. Under the license agreement between Roche and Chugai, Chugai obtained exclusive rights for the development and marketing of CT-388 in Japan. Roche will receive an upfront fee and milestone payments.

“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. Chugai will work closely with Roche to advance the development of CT-388 to deliver it to patients in Japan as soon as possible,” said Dr. Osamu Okuda, Chugai’s President and CEO.

In the overseas Phase I clinical study (CT-388-101 trial) of CT-388, adults with obesity received weekly subcutaneous injections of CT-388 for 24 weeks, resulting in a placebo-adjusted mean weigh reduction of -18.8% (p<0.001) at week 24, demonstrating clinically meaningful and statistically significant weight reduction compared to placebo. In the CT-388 treatment group, 100% of participants achieved >5% weight reduction, 85% achieved >10%, 70% achieved >15%, and 45% achieved >20% weight reduction. The treatment was well-tolerated, with mostly mild to moderate gastrointestinal side effects commonly observed with incretin-based therapies. CT-388 is currently in Phase II clinical trials overseas for obesity with type 2 diabetes.

Chugai will continue to effectively utilize the research and development resources of the Roche Group to find innovative new drugs so as to satisfy unmet medical needs.

About the CT-388-101 Trial
The CT-388-101 trial is a Phase I randomized, double-blind, placebo-controlled study in adult participants with overweight or obesity and in participants with obesity and type 2 diabetes, evaluating CT-388 from low to high doses through single ascending doses, multiple ascending doses, and repeated dosing for up to 24 weeks. The trial enrolled 129 participants. The primary endpoint was the safety and tolerability of CT-388, with secondary endpoints including effects on weight and glucose homeostasis. The pharmacokinetics and other pharmacodynamic effects of CT-388 were also evaluated.

About CT-388
CT-388 is a GLP-1/GIP receptor agonist administered by weekly subcutaneous injection being developed for the treatment of obesity and type 2 diabetes. It is designed to show high activity at both GLP-1 and GIP receptors while minimizing β-arrestin recruitment at either receptor. This biased signaling is expected to substantially reduce receptor internalization and associated desensitization, leading to sustained pharmacological effects.

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