Roche Holding AG reported positive Phase II outcomes for CT-388, its investigational dual GLP-1/GIP receptor agonist for people living with obesity. Company data show a 22.5% placebo-adjusted weight loss at the 48-week mark, and a majority response on the highest evaluated dose.
In the trial, 54% of participants receiving the 24 mg dose achieved resolution of obesity. The announcement highlights both the magnitude of weight reduction and the proportion of subjects who reached a clinically meaningful threshold at that dose level.
Safety and tolerability
Roche said CT-388 demonstrated a safety and tolerability profile that was generally in line with expectations for this class of therapies. The company reported no new or unexpected safety signals and characterized adverse events as mild to moderate. Those statements indicate that, within the Phase II population, the drug did not reveal safety concerns beyond what is typical for GLP-1/GIP receptor agonists.
Next steps and data dissemination
The company plans to present the full set of Phase II results at an upcoming medical congress, where more detailed efficacy and safety data will be disclosed. Roche also indicated that it expects to initiate the CT-388 Phase III development program this quarter.
Implications for sectors
- Healthcare and pharmaceutical development: Positive Phase II efficacy and a favourable tolerability statement support further clinical advancement into late-stage testing.
- Biotechnology: Progression to Phase III may influence R&D planning and competitive positioning among companies developing obesity treatments.
Limitations of the announced information
The company has not yet released the full dataset in the public domain; detailed efficacy breakdowns, subgroup analyses, and complete safety tables are pending presentation at the medical congress. Additionally, while Roche has indicated a Phase III start this quarter, outcomes of those future trials are not reported and remain to be seen.