Roche has reported positive top line results from its Phase II trial in obesity, where once-weekly subcutaneous injection of CT-388 resulted in significant weight loss.
The randomised, double-blind, multi-centre study enrolled 469 adults with obesity or overweight plus at least one comorbidity, excluding those with type 2 diabetes (T2D).
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In the trial, participants receiving up to 24mg of CT-388 had a placebo-adjusted weight loss of 22.5% (efficacy estimand) at 48 weeks. For the treatment-regimen estimand, weight loss achieved was 18.3%.
Among participants with pre-diabetes at baseline treated with CT-388 at 24mg, 73% reached normal blood glucose levels by week 48, against 7.5% on placebo.
Most of the gastrointestinal adverse events were mild-to-moderate, and the discontinuation rate due to side effects was low, 5.9% in the CT-388 groups versus 1.3% for placebo.
The trial’s primary goal was percent change in body weight from baseline to week 48.
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By GlobalDataFull results are set for presentation at a future medical congress.
Roche has designated CT-388 as a fast-track asset and is currently investigating it in another Phase II trial (CT388-104) involving overweight or obese adults with T2D. The company will launch Phase III trials (Enith1 and Enith2) later this quarter.
The therapy is also considered a combination asset for petrelintide.
Roche’s chief medical officer and global product development head Levi Garraway said: “We are pleased to see such meaningful weight loss in people treated with CT-388.
“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.”
In November 2025, Roche reported that its Phase III ALLEGORY trial of Gazyva / Gazyvaro (obinutuzumab) in adult patients with systemic lupus erythematosus (SLE) met its primary objective.
