Roche Holding AG announced positive topline results from two arms of an ongoing multi-part Phase I clinical trial for CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity. The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks (p <0.001). The full study data will be presented at an upcoming medical meeting.

Obesity is one of the most urgent health challenges in the world with extensive comorbidities, such as type 2 diabetes, cardiovascular disease, liver disease, and chronic kidney disease. More than four billion people - about 50% of the world?s population - are estimated to be impacted by obesity or will be overweight by 2035. CT-996 was well tolerated, with mostly mild or moderate gastrointestinal-related adverse events, consistent with the safety profile of the incretin drug class.

There were no treatment discontinuations related to the study drug. The study results also showed that blood levels of CT-996 were largely unaffected either during fasting or after a standardised high-fat meal. Thus, CT-996 could potentially be dosed without regard to meal timing, thereby affording greater dosing flexibility for patients.

Based on the study data, CT-996 is anticipated to be used not only as a therapy for achieving glycaemic control and inducing weight loss, but also potentially for oral weight maintenance therapy following weight loss induced by injectables. Despite numerous approved treatments, the trajectory for people with obesity or its comorbidities has not changed significantly; these conditions remain underdiagnosed and undertreated so their impact on society continues to grow. Oral and injectable incretin modalities are critical to address the high unmet need.

They may not only offer broader access to patients living with obesity, but together, they could also support the prevention of obesity-related comorbidities or complications such as type 2 diabetes and heart disease among many others. About Roche?s metabolism portfolio Obesity is a heterogeneous disease and the company's R&D portfolio of incretin-based clinical and preclinical assets has great potential to address patients? needs by providing treatments as mono and combination therapy for obesity, diabetes and various other cardiometabolic indications.

The company are developing a broad portfolio of foundational assets that range from orals to injectables, as well as molecules with new modes of action to address the multiple needs of patients living with obesity. The company's differentiated incretin portfolio includes: CT-388, an investigational dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes, currently in Phase II. Injected subcutaneously once a week, it is being developed both as a standalone and possibly also in combination, and has the potential to be a best in class therapy for chronic weight management, type 2 diabetes, and could be expanded to other indications.

CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity, currently in Phase I, with the potential to be a best-in-class oral treatment for type 2 diabetes and chronic weight management. CT-868, an investigational, once-daily, subcutaneously injected dual GLP-1/GIP receptor agonist currently in Phase II with the potential to be a first in class treatment for glycaemic control as an adjunct to insulin in patients living with type 1 diabetes. Incretins are gut hormones secreted after food intake that play a role in modulating blood glucose by stimulating insulin secretion and suppress appetite.

Emerging scientific data show a wider biologic effect of incretins in multiple organs including the liver, heart and brain, suggesting they may have a broader role in the body beyond glucose modulation. Over the past few years, incretins have been clinically validated as targets and are now the emerging standard of care therapies in obesity, but could also be effective in other metabolic indications, as well as in cardiovascular and chronic kidney disease.