Roche subsidiary Genentech has unveiled promising Phase Ib results for its investigational weight-loss treatment, CT-388. The data suggests that a once-weekly subcutaneous injection of CT-388 can significantly reduce body weight in obese individuals.
After 24 weeks of monitoring, CT-388 demonstrated a substantial weight loss of 18.8% compared to the placebo group. This effect was statistically significant, with a p-value of less than 0.001. Moreover, all patients treated with CT-388 experienced over 5% weight loss, and 45% of participants achieved a reduction of more than 20% in their body weight.
A detailed subgroup analysis revealed that all pre-diabetic participants normalized their blood glucose levels after 24 weeks of treatment with CT-388. In contrast, the placebo group displayed no meaningful improvement in glycemic control.
Regarding safety, CT-388 was well-tolerated, with most side effects being mild to moderate. No unexpected safety issues were reported, and the adverse events were consistent with other drugs in the incretin class.
Levi Garraway, Chief Medical Officer and head of global product development at Roche, described the data as "highly encouraging," emphasizing CT-388's potential to become a leading therapy for long-lasting weight loss and glucose management. Roche plans to continue developing CT-388 as a treatment for obesity and type 2 diabetes.
CT-388 was initially developed by Carmot Therapeutics and is a dual agonist of the GLP-1 and GIP receptors. This dual agonist approach shows minimal recruitment of β-arrestin proteins, which could otherwise interfere with receptor signaling and reduce the treatment's effectiveness. This biased mechanism of action helps prevent desensitization to the treatment and prolongs its pharmacological benefits. CT-388 is administered through a once-weekly subcutaneous injection.
Roche acquired Carmot Therapeutics in December 2023 for $2.7 billion and is currently conducting a multi-part, multi-cohort Phase I trial of CT-388 in overweight or obese patients. The acquisition also included other promising obesity treatments. One such candidate is CT-868, which is in Phase II trials and is also a dual agonist of the GLP-1 and GIP receptors, designed for daily subcutaneous injection. Another candidate, CT-996, is an early-stage oral small molecule GLP-1 agonist.
The recent data release positions Roche as a potential competitor in the lucrative obesity market, which is largely dominated by Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Zepbound (tirzepatide). Despite efforts to ramp up production, these frontrunners have struggled to meet the high demand for weight-loss treatments, resulting in drug shortages.
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