Genentech has announced positive topline results from a phase 2 trial of CT-388, its investigational therapy to treat obesity.
The study found that, at 48 weeks, participants receiving a once-weekly subcutaneous injection of CT-388 had a significant and clinically meaningful weight loss of 22.5% without reaching a weight loss plateau. Of participants on the 24 mg dose, 54% were no longer obese vs 13% in the placebo group.
The 24mg dose showed particularly significant results – at week 48, more than a quarter of patients on this dose had reduced their weight by more than 30% and just under half of patients had reduced their weight by 20%.
Of the study participants who were pre-diabetic at the beginning of the study, 73% achieved normal blood sugar levels at 48 weeks on a 24mg dose, compared to only 7.5% of those receiving placebo.
CT-388 was found to have a favourable tolerability and safety profile. The rate of discontinuation relating to adverse events was low in both the treatment and placebo arms of the study.
Complete results from the CT388-103 study will be presented at a future medical meeting and the phase 3 clinical trial of CT-388 in obesity is expected to start this quarter.
Obesity has been recognised as the most significant single risk factor for chronic disease worldwide. It is thought that more than four billion people will be overweight or obese by 2035, making up over half of the world’s population. As well as significantly affecting quality of life, obesity and its comorbidities place significant financial strain on healthcare systems.
CT-388 is a dual glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist that is under development for the treatment of obesity, as well as type 2 diabetes and other comorbidities associated with obesity. It is designed to tackle obesity and its comorbidities by both reducing appetite and regulating blood sugar.
Levi Garraway, chief medical officer and head of Global Product Development at Genentech, said: “The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development programme as we advance to phase 3 trials.”