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Roche Says Investigational Once-Weekly "Twincretin" Shows Promise in Adults with Obesity in Early Stage Clinical Trial
In the phase 1b trial, treatment with once-weekly subcutaneous CT-388 led to a statistically significant mean placebo-adjusted weight loss of nearly 20%.
In otherwise healthy adults with obesity (BMI>30 kg/m2), a once-weekly subcutaneous injection of the investigational agent CT-388 was associated with clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (P < .001) after 24 weeks of treatment, according to a press announcement from manufacturer Roche.
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At the 24-week mark, all participants in the company's phase 1b clinical trial treated with CT-388, a dual glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist, achieved weight loss from baseline greater than 5%, while 70% achieved more than 15% and 45% achieved a more than 20% reduction in body weight, Roche reported. In a subgroup of participants identified as having "prediabetes" at study baseline, treatment with CT-388 "normalised glycemia" for all of them at 24 weeks. Glycemic status for placebo-treated participants was unchanged.
The investigational "twincretin" is in development for treatment of obesity and type 2 diabetes (T2D) and in this study exhibited safety and tolerability consistent with its class of drugs.
“We are very pleased to see the significant and clinically meaningful weight loss in people treated with CT-388,” Levi Garraway, MD, PhD, chief medical officer, and head of global product development for Roche said in the company statement. “The results are highly encouraging for further development of CT-388 for both obesity and type 2 diabetes and underscore its potential to become a best-in-class therapy with durable weight loss and glucose control.”
The company expects to report data from the cohort with T2D being treated with CT-388 for 12 weeks in the second half of the year.
The placebo-controlled Phase Ib trial (NCT04838405) enrolled approximately 96 participants with overweight or obesity with or without T2D. The study's primary endpoint is safety and tolerability of CT-388 and secondary endpoints include effects on body weight and glucose homeostasis. The final analysis will also include pharmacokinetic and other pharmacodynamic effects of CT-388.
The CT-388 molecule will be potent on both GLP-1 and GIP receptors but exhibit minimal to no ß-arrestin recruitment on either one, according to Roche. The goal is to achieve prolonged pharmacologic activity by way of this biased signalling, which "significantly minimises receptor internalisation and consequent desensitisation," the company stated. It is currently being studied in a multipart, multicohort Phase 1 clinical trial in people with overweight/obesity with and without T2D.
