Genentech Reports Positive Phase Ib Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People With Obesity
– Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p < 0.001) –
– At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% and 45% achieved >20% weight loss –
– In a subgroup with pre-diabetes at baseline, CT-388 treatment normalized glycemia in all patients, indicating its strong impact on glucose homeostasis –
– No new or unexpected safety signals were detected. Overall, CT-388 demonstrated a safety and tolerability profile consistent with its drug class –
“We are very pleased to see the significant and clinically meaningful weight loss in people treated with CT-388,” said
Obesity is one of the most urgent health challenges in the world with extensive comorbidities, such as type 2 diabetes, cardiovascular diseases, steatohepatitis and chronic kidney disease. Over four billion people – about 50% of the world’s population – are estimated to be impacted by obesity or being overweight by 2035. The growing number puts an incredible strain on societies and healthcare systems around the world.
CT-388 belongs to the class of incretin-based medicines that aim to regulate blood sugar and reduce appetite. It selectively targets and activates two specific receptors in the body, known as GLP-1 and GIP, which integrate nutrient-derived signals to control food intake, energy absorption and assimilation. It is hypothesized that the dual targeting effect of CT-388 could result in a meaningful durable glucose reduction and weight loss, in addition to a favorable safety profile.
An additional cohort from the ongoing placebo-controlled Phase Ib trial of CT-388 will evaluate obese patients (BMI>30 kg/m2) with type 2 diabetes over a 12-week treatment duration.
About the CT-388 study
The CT-388-101 trial is a multi-arm, multi-cohort Phase Ib randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-388 in otherwise-healthy adult participants with overweight or obesity and in participants with obesity and type-2 diabetes mellitus. The primary endpoint of the trial is safety and tolerability of CT-388; secondary endpoints include its effect on body weight and glucose homeostasis. Pharmacokinetics and other pharmacodynamic effects of CT-388 were also assessed.
About CT-388
CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes (T2D). CT-388 was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no ß-arrestin recruitment on either receptor. This biased signaling significantly minimizes receptor internalization and consequent desensitization, which is expected to lead to prolonged pharmacological activity. It is currently being studied in a multi-part, multi-cohort Phase 1 clinical trial in people with overweight/obesity with and without T2D.
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