Roche's CT-388 Shows Positive Phase I Results in Obesity

Roche has announced promising findings from a Phase I clinical trial evaluating the efficacy of CT-388, a dual GLP-1/GIP receptor agonist, in treating obesity and type 2 diabetes. Conducted over 24 weeks, the study revealed that a once-weekly subcutaneous injection of CT-388 led to a significant reduction in weight among healthy adults with obesity, compared to a placebo group. The data showed a mean placebo-adjusted weight loss of 18.8%, which is both statistically significant and clinically meaningful (p < 0.001).

At the 24-week mark, 100% of the participants treated with CT-388 experienced a weight loss of more than 5%, with 85% losing over 10%, 70% losing more than 15%, and 45% losing over 20% of their body weight. The treatment was generally well-tolerated, with mild to moderate gastrointestinal side effects being the most common, consistent with the incretin class of medications to which CT-388 belongs.

Additionally, all participants who had pre-diabetes at the beginning of the trial achieved normalized blood sugar levels after 24 weeks of treatment with CT-388. This was in stark contrast to the placebo group, where glycemic status largely remained the same over the study period.

Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development, expressed satisfaction with the results, noting the significant and clinically meaningful weight loss observed in the CT-388 group. He emphasized the potential of CT-388 to become a leading therapy for both obesity and type 2 diabetes, citing its promising dual impact on weight loss and glucose control.

Obesity is a pressing global health issue, associated with a host of comorbidities including type 2 diabetes, cardiovascular diseases, steatohepatitis, and chronic kidney disease. By 2035, it is estimated that over four billion people, approximately half of the global population, will be affected by obesity or being overweight, significantly burdening healthcare systems worldwide.

CT-388 is an incretin-based drug designed to regulate blood sugar and reduce appetite by selectively targeting and activating the GLP-1 and GIP receptors. These receptors play a critical role in managing food intake and energy absorption. The dual-targeting mechanism of CT-388 is hypothesized to result in sustained glucose reduction and weight loss, alongside a favorable safety profile.

The ongoing Phase I trial of CT-388 is a multi-arm, randomized, double-blind, placebo-controlled study. It aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CT-388 in adults with obesity, with or without type 2 diabetes. The primary endpoint is to assess safety and tolerability, while secondary endpoints include effects on body weight and glucose homeostasis. Pharmacokinetic and other pharmacodynamic effects are also being examined.

An additional cohort within this trial will assess the impact of CT-388 on obese patients with type 2 diabetes over a 12-week period. Roche anticipates sharing data from this cohort in the latter half of 2024.

In summary, CT-388 has shown substantial promise in early trials, providing significant weight loss and improving glycemic control in individuals with obesity and pre-diabetes. This positions CT-388 as a potential leading treatment option for managing obesity and type 2 diabetes, pending further clinical trials and approvals.