Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), on Wednesday reported positive topline results from its Phase I clinical trial for CT-996, an investigational, once-daily, oral GLP-1 receptor agonist. The trial showed a significant placebo-adjusted mean weight loss of -6.1% in participants with obesity over four weeks (p < 0.001).

Pharmacokinetic data supports a once-daily oral dosing regimen for CT-996, which was well-tolerated with no unexpected safety signals. Mild or moderate gastrointestinal-related adverse events were consistent with the drug class. The study indicated that CT-996's efficacy was unaffected by fasting or high-fat meals, offering dosing flexibility for patients.

Obesity impacts over four billion people globally and is associated with numerous comorbidities. CT-996 aims to address this by providing a new therapy for glycemic control and weight loss, potentially serving as oral maintenance therapy following injectable treatments.

The CT-996-201 trial (NCT05814107) is a multi-part, randomised, double-blind, placebo-controlled Phase I study. It evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight or obese adults, with and without type 2 diabetes. Following promising Phase I results, CT-996 will advance to Phase II development.

CT-996 is part of Genentech's extensive R&D portfolio focused on incretin-based therapies, addressing obesity, diabetes and cardiometabolic conditions. Other pipeline assets include CT-388 and CT-868, which are in various stages of clinical trials and offer potential treatment for chronic weight management and glycemic control.

Genentech, founded over 40 years ago, continues to innovate in biotechnology, developing medicines for serious medical conditions from its headquarters in South San Francisco, California.