Roche | MEDIA
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[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity
Roche announced positive topline results from CT388-103, a Phase II clinical trial of CT-388, an investigational once-weekly dual GLP-1/GIP receptor agonist for treating obesity. At the highest 24 mg dose, CT-388 achieved a statistically and clinically significant placebo-adjusted weight loss of 22.5% at 48 weeks without reaching a plateau. This robust efficacy resulted in 54% of participants on the 24 mg dose achieving resolution of obesity, compared to 13% in the placebo group. The treatment also showed a clear dose-response relationship, with high percentages of participants achieving substantial weight loss thresholds, including 95.7% losing 5% or more of their body weight. Furthermore, 73% of pre-diabetic participants on the 24 mg dose achieved normal blood glucose levels at week 48, versus 7.5% in the placebo group. CT-388 demonstrated a safety and tolerability profile consistent with its drug class, with the majority of gastrointestinal adverse events being mild-to-moderate and a low discontinuation rate due to adverse events. Roche is highly confident in the drug's potential, reinforcing this by advancing CT-388—a fast-track asset—to Phase III clinical trials, expected to begin this quarter. The dual GLP-1/GIP mechanism aims to reduce appetite and regulate blood sugar via biased signaling to prolong pharmacological activity. Obesity is a major global health risk, projected to affect over four billion people by 2035, highlighting the need for transformative treatments like CT-388. Roche is accelerating the development of CT-388, which is also being investigated in an additional Phase II study and considered a combination therapy asset.