Roche has reported positive topline data from the ongoing multi-part Phase I clinical trial of CT-996, an oral GLP-1 receptor agonist, to treat type 2 diabetes (T2D) and obesity.
Named the CT-996-201 trial, the multi-part, multi-cohort, double-blind, randomised, placebo-controlled, single- and multiple- ascending dose study has completed two arms so far
It is designed to assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of CT-996 in overweight or obese adults, irrespective of the T2D status.
The first two parts of the trial, involving single and multiple ascending doses in obese participants without, T2D have been concluded.
The third part is planned to commence in the fourth quarter of this year and will enrol 30 participants with obesity and T2D.
Safety and tolerability of CT-996 is the trial’s primary endpoint.
Secondary outcomes are to assess the drug's impact on body weight and glucose regulation, as well as the pharmacokinetics of CT-996.
Results from the completed sections have shown a clinically meaningful weight reduction of -6.1% in four weeks among participants without T2D.
The trial also highlighted CT-996's well-tolerated nature, with most adverse events being mild or moderate gastrointestinal issues, aligning with the expected safety profile of incretin-based therapies.
Further findings indicate that CT-996's absorption is not significantly impacted by fasting or a high-fat meal, suggesting the potential for flexible dosing schedules.
With the successful Phase I outcomes, CT-996 is set to progress into Phase II clinical development.
Roche Global Product Development head and chief medical officer Levi Garraway said: “We are pleased to see the clinically meaningful weight loss in people treated with our oral GLP-1 therapy CT-996, which could eventually help patients address both chronic weight management and glycaemic control indications.
“Following our data for CT-388, this is the second positive readout in less than three months from our growing metabolic pipeline, which includes both oral and injectable options to address patients' needs across a spectrum of related diseases."
Roche recently reported that its Phase II/III SKYSCRAPER-06 trial of tiragolumab, along with Tecentriq (atezolizumab) and chemotherapy as first-line treatment for non-squamous non-small cell lung cancer, failed to meet primary endpoints.
