On July 15th, Roche released phase Ib clinical data of its GLP-1/GIP small molecule agonist CT-388, which showed that higher doses had not yet reached peak weight loss at 6 months.

A summary to be published at the annual meeting of the European diabetes Research Association in Madrid in September shows that the weight loss effect of CT-388 in 24 weeks has not stabilized, which means that it may achieve a better weight loss effect than the previously announced average weight loss rate of 18.8%.

1. 45% of patients lose 20% weight

In December 2023, Roche announced the signing of a final acquisition agreement with Carmot Therapeutics, agreeing to acquire the latter for $3.1 billion, thereby obtaining CT-388.

Roche has been developing the GLP-1 receptor agonist drug Taspoglutide, which entered phase 2 clinical trials in 2008. However, by 2011, Roche had abandoned the candidate drug due to its side effects.

This acquisition also marks Roche's official return to the GLP-1 field.

There are three main candidate drugs for subcutaneous and oral GLP-1 drugs in the clinical stage under Carmot Therapeutics, among which CT-388 is the most advantageous product.

CT-388 is a weekly subcutaneous injection of double GLP-1/GIP receptor agonist, which is being developed for the treatment of obesity and type 2 diabetes (T2D).

On May 16th, Roche disclosed the Phase I clinical results of CT-388: after 24 weeks, an average weight loss of 18.8% was achieved by subcutaneous injection of CT-388 once a week (adjusted for placebo, p<0.001); 100% of participants receiving CT-388 treatment experienced a weight loss of>5%, 70% of subjects experienced a weight loss of>15%, and 45% of subjects experienced a weight loss of>20%.

In addition, CT-388 has good tolerability to treatment, with mild to moderate gastrointestinal related adverse events being the most common, consistent with the enterotropins to which CT-388 belongs. All subjects in pre diabetes status at baseline recovered to normal blood glucose level 24 weeks after receiving CT-388 treatment, while the blood glucose status of subjects receiving placebo treatment remained basically unchanged during this period.

The earlier released data was CT-3884 week weight loss data, with a result of 8.4% weight loss at that time.

Manu Chakravarthy, senior vice president and global director of cardiovascular, kidney and metabolic product development of Roche, said in an interview that the company plans to launch a phase II study later in 2024 to evaluate weight loss, cardiovascular disease and type 2 diabetes improvement and other results.

Chakravarthy also added that the dosage regimen will be further adjusted using the Phase II study.

The initial dose for patients receiving CT-388 treatment was 5 milligrams, with one single arm study increasing the dose to 8 milligrams and another single arm study increasing the dose

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