Genentech announces topline results from CT388-103 trial

Genentech, a member of Roche (RHHBY), announced topline results from CT388-103, a Phase II clinical trial of CT-388, an investigational dual GLP-1/GIP receptor agonist being developed for the treatment of obesity. The study found that once-weekly subcutaneous injections of CT-388 resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% 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 greater than or equal to 5%, 87% achieved greater than or equal to 10%, 47.8% achieved greater than or equal to 20%, and 26.1% achieved greater than or equal to30%. Overall, 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. In addition, the treatment discontinuation rate due to adverse events was low. The full results of the study will be presented at an upcoming medical congress. The company said, “Since integrating CT-388 into the pipeline, we have designated it within Genentech as a fast-track asset and significantly accelerated its clinical development with the goal to bring this potential therapy to patients as soon as possible. CT-388 is currently being investigated in an additional Phase II study to evaluate the efficacy, safety and tolerability of CT-388 in participants who are living with obesity or are overweight and have type 2 diabetes. The Phase III clinical trial program of CT-388 in obesity is expected to start this quarter. In addition to offering robust efficacy as a standalone therapy, CT-388 also plays a key role in unlocking the promise of our obesity pipeline and is considered as a combination asset for petrelintide.”