(RTTNews) - Genentech, a biotechnology firm and member of the Roche Group (RHHBY,ROG.SW), announced positive topline results from its Phase 2 clinical trial of CT-388 in obesity.
CT-388 is an investigational once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity, type 2 diabetes, and other obesity-related comorbidities. Roche acquired CT-388 as a Phase-2-ready asset as part of its January 2024 acquisition of Carmot Therapeutics.
In the phase 2 study, dubbed CT388-103, once-weekly subcutaneous injections of CT-388 at 24 mg achieved a statistically significant placebo-adjusted weight loss of 22.5% at 48 weeks, without reaching a weight loss plateau.
According to the company, at Week 48, among participants receiving the 24 mg dose of CT-388, 95.7% lost at least 5% of their body weight, 87% lost at least 10%, 47.8% lost at least 20%, and 26.1% lost at least 30%.
Among participants receiving the 24 mg dose, 54% achieved resolution of obesity (BMI 30 kg/m2), compared with just 13% in the placebo group.
Additionally, 73% of participants who were pre-diabetic at baseline achieved normal blood glucose levels, compared with 7.5% in the placebo group.
CT388-103 was found to be well-tolerated, with most gastrointestinal side effects being mild to moderate, common in this class of drugs. In addition, the treatment discontinuation rate due to adverse events was low, with 5.9% in the CT-388 arms compared with 1.3% in the placebo arm.
Obesity is recognised as the greatest single risk factor for chronic disease globally. By 2035, over four billion people, which is more than half of the global population, are projected to be living with excess weight or obesity.
The full results of the study will be presented at an upcoming medical congress.
In addition, CT-388 is currently being investigated in an additional Phase 2 study (CT388-104) in participants who are living with obesity or are overweight and have type 2 diabetes (T2D). The Phase 3 clinical trial program of CT-388 in obesity, dubbed Enith1 and Enith2, is expected to start this quarter.
"The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development program as we advance to Phase III trials", said Levi Garraway, chief medical officer and head of Global Product Development.
RHHBY has traded between $34.75 and $56.63 over the last 1 year. The stock closed Monday's trade at $56.12, up 1.61%.
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