Roche has announced positive outcomes from the Phase I clinical trial of CT-388, a novel dual GLP-1/GIP receptor agonist, which is being developed as a once-weekly subcutaneous injection for the treatment of obesity and type 2 diabetes. The trial results revealed significant weight loss and improved glycemic control in participants, positioning CT-388 as a potentially transformative therapy in the management of these conditions.

Significant Weight Loss and Glycemic Improvements

The study demonstrated that CT-388 led to a mean placebo-adjusted weight loss of 18.8% over 24 weeks, a result that is both statistically significant (p-value < 0.001) and clinically meaningful. Impressively, 100% of the participants treated with CT-388 achieved more than 5% weight loss, 85% surpassed 10% loss, 70% exceeded 15%, and 45% achieved over 20% weight reduction. Additionally, all participants with a pre-diabetes condition at the start of the trial returned to normoglycemic levels by the end of the study, while those on placebo did not show similar improvement.

Encouraging Results for Further Development

Dr. Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, expressed enthusiasm about the trial outcomes: “We are very pleased to see the significant and clinically meaningful weight loss in people treated with CT-388. The results are highly encouraging for further development of CT-388 for both obesity and type 2 diabetes and underscore its potential to become a best-in-class therapy with durable weight loss and glucose control.”

Addressing a Global Health Challenge

Obesity is a critical health issue globally, with predictions suggesting that approximately 50% of the world’s population will be affected by obesity or overweight by 2035. The condition is linked with numerous comorbidities including type 2 diabetes, cardiovascular diseases, and chronic kidney disease, placing a significant burden on healthcare systems worldwide.

Incretin-Based Mechanism of CT-388

CT-388 is designed to target and activate GLP-1 and GIP receptors in the body, which regulate blood sugar and reduce appetite. This dual receptor activation is believed to offer substantial benefits in glucose reduction and weight management, with a favorable safety profile highlighted by minimal to no ß-arrestin recruitment, which helps in reducing receptor desensitization and prolonging the drug’s pharmacological effects.

Ongoing Research and Future Prospects

An additional cohort within the ongoing Phase I trial will assess the effects of CT-388 on obese patients with type 2 diabetes over a 12-week period, with results expected in the latter half of 2024. This research is part of a broader effort to validate CT-388’s efficacy and safety, ensuring it meets the stringent requirements for eventual market approval.

The preliminary results from Roche’s CT-388 trial signify a major step forward in the treatment of obesity and type 2 diabetes. If subsequent trials confirm these findings, CT-388 could revolutionize the standard care for these prevalent and impactful health issues, offering patients a more effective and manageable treatment option.

  clinical trial results, CT-388, Diabetes management, obesity treatment, Roche, Roche CT-388