Roche CT-388 Obesity Drug Posts Strong Phase II Results

Roche today announced strong Phase II results for its investigational Roche CT-388 obesity drug, showing deep and sustained weight loss in people with obesity. The once-weekly injectable therapy delivered a placebo-adjusted weight loss of 22.5% over 48 weeks, with no sign of a plateau at the highest tested dose.

The Phase II trial, known as CT388-103, evaluated escalating doses of CT-388 up to 24 mg. Results showed a clear dose-response effect. Using the treatment-regimen estimand, patients achieved an 18.3% placebo-adjusted reduction in body weight. Roche said the findings point to clinically meaningful and durable outcomes.

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At the 24 mg dose, results stood out. Nearly all participants, 95.7%, lost at least 5% of their body weight. About 87% lost 10% or more, while 47.8% lost at least 20%. More than a quarter of patients achieved weight loss of 30% or greater, levels rarely seen in obesity studies.

The Roche CT-388 obesity drug also showed metabolic benefits. Among participants who were pre-diabetic at baseline, 73% returned to normal blood glucose levels by week 48, compared with 7.5% on placebo.

CT-388 was generally well tolerated. Most side effects were mild to moderate gastrointestinal issues, consistent with the incretin drug class. Discontinuation due to adverse events remained low at 5.9%, versus 1.3% for placebo.

“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 has fast-tracked CT-388, with another Phase II study underway in patients with obesity and type 2 diabetes. Its Phase III program, Enith1 and Enith2, is expected to begin this quarter, as obesity continues to rise toward affecting more than four billion people worldwide by 2035.