On January 20, the website of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) announced that Roche's Class 1 new drug RO7795081 has been approved for clinical trials in China, intended for long-term weight management in overweight or obese patients. Public information shows that RO7795081 (CT-996) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist . Roche previously entered into a merger agreement with Carmot Therapeutics, acquiring the company for approximately $3.1 billion, thereby gaining access to three GLP-1 investigational therapies, one of which is CT-996.

Publicly available information shows that, unlike endogenous GLP-1 hormones, CT-996 is specifically designed as a biased GLP-1 receptor agonist that activates cAMP signaling with minimal recruitment of β-arrestin. These precisely modulated signaling properties promise to lead to robust glycemic control, resulting in significant weight loss and good tolerability.

In July 2024, Roche announced positive results from a Phase 1 clinical trial of CT-996, which evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in healthy adults who were overweight or obese, with or without type 2 diabetes. Analysis showed that after 4 weeks, patients in the CT-996 group experienced a 7.3% weight loss, compared to a 1.2% loss in the placebo group; the difference was clinically significant (6.1%). Pharmacokinetic data support a once-daily oral dosing regimen for CT-996. Furthermore, the results indicated that CT-996 levels in the blood were not significantly affected during fasting or after a standardized high-fat meal. Therefore, CT-996 dosing may not require consideration of meal timing, potentially offering greater dosing flexibility.

Based on the data from this study, Roche anticipates that CT-996 can not only be used for the treatment of blood sugar control and weight loss, but may also be used as an oral weight maintenance therapy for patients after receiving injectable weight loss therapy.

According to ClinicalTrials.com , Roche is currently conducting two Phase 2 clinical trials internationally, one for obese patients and the other for patients with type 2 diabetes. This approval for clinical trials in China indicates that the product will soon begin clinical research in the country.

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