Roche (RHHBY) announced positive 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.
After four weeks of treatment, CT-996 exhibited a clinically significant weight loss of 7.3%, compared to a 1.2% weight loss in the placebo group.
According to the company, 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.1 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, Roche said.
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