Roche’s GLP‑1/GIP receptor agonist CT‑388 demonstrated strong efficacy in patients with obesity | iPharmaCenter
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Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity.
A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) vs. 13% in the placebo group.
CT-388 demonstrated a safety and tolerability profile generally consistent with its drug class with no new or unexpected safety signals.
The Phase 2 study found that once-weekly subcutaneous injections of CT-388 (titrated up to 24 mg) resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks. A clear dose-response relationship on the weight loss was observed. For the treatment-regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3%. At week 48 for the 24 mg dose, 95.7% of CT-388 treated participants achieved a weight loss of ≥5%, 87% achieved ≥10%, 47.8% achieved ≥20%, and 26.1% achieved ≥30%. 73% of participants who were pre-diabetic at baseline and treated with CT-388 at 24 mg achieved normal blood glucose levels at week 48 compared to 7.5% in the placebo group.
The treatment was well-tolerated, with the majority of gastrointestinal-related adverse events being mild-to-moderate, generally consistent with the incretin class of medicines.
Obesity is recognised as the greatest single risk factor for chronic disease globally. By 2035, over four billion people (more than half of the global population) are projected to be living with excess weight or obesity, a trend affecting nearly every country. T
Since integrating CT-388 into the Roche pipeline, we have designated it as a fast-track asset and significantly accelerated its clinical development to bring this potential therapy to patients. CT-388 is currently being investigated in an additional Phase II study (CT388-104) to evaluate the efficacy, safety and tolerability of CT-388 in participants who are living with obesity or are overweight and have T2D.
The phase III clinical trial programme of CT-388 in obesity (Enith1 and Enith2) is expected to start this quarter.
About the CT-388 (103) Phase II study [NCT06525935]
The multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding Phase II trial was designed to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in 469 people with obesity. It includes adults with obesity (BMI≥30.0 kg/m2) or overweight (BMI ≥27.0 and <30.0 kg/m2) with at least one weight-related comorbidity without type 2 diabetes and evaluated five dosing cohorts with different up-titration schemes with 24mg being the highest dose tested. The primary endpoint was percent change in body weight from baseline to week 48.
About CT-388
About Roche’s GLP‑1/GIP receptor agonist CT‑388
CT-388 is an investigational once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity, type 2 diabetes, and other obesity-related comorbidities. It aims to reduce appetite and regulate blood sugar by selectively targeting and activating both receptors which integrate nutrient-derived signals to control energy homeostasis.
CT-388 was designed to have potent activation of both GLP-1 and GIP receptors, but with minimal to no ß-arrestin recruitment on either receptor. This biased signalling significantly minimises receptor internalisation and consequent desensitisation, which is expected to lead to prolonged pharmacological activity.
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