Swiss pharma giant Roche has announced  that its investigational drug CT-388 has achieved striking results in a Phase II trial targeting obesity.

 

The CT388-103 study found that once-weekly injections of CT-388, titrated up to 24 mg, drove significant and clinically meaningful weight loss of 22.5% versus placebo (efficacy estimand) over 48 weeks, without hitting a weight-loss plateau. A clear dose-response relationship was observed. Using the treatment-regimen estimand, participants experienced 18.3% placebo-adjusted weight loss.

 

At the highest dose of 24 mg, outcomes were especially dramatic: 95.7% of participants lost at least 5% of their body weight; 87% lost 10% or more; 47.8% lost 20% or more; 26.1% lost 30% or more.

 

For participants who were pre-diabetic at baseline, 73% treated with CT-388 achieved normal blood glucose at week 48, compared to just 7.5% on placebo.

 

The treatment was generally well-tolerated, with mostly mild-to-moderate gastrointestinal side effects, consistent with the incretin class. Discontinuation due to adverse events was low: 5.9% in CT-388 arms versus 1.3% for placebo. Full results will be presented at an upcoming medical congress.

 

“We are pleased to see such meaningful weight loss in people treated with CT-388,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development programme as we advance to Phase III trials.”

 

Roche is accelerating the development of CT-388, now considered a fast-track asset, with an additional Phase II trial (CT388-104) underway for participants with obesity or overweight and type 2 diabetes. The Phase III programme, Enith1 and Enith2, is expected to launch this quarter.

 

Obesity is the single greatest global risk factor for chronic disease, projected to affect over four billion people by 2035—more than half the world’s population.