Roche (SIX: RO) reported positive Phase II results for enicepatide, its investigational once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes (T2D) and obesity. The highest dose (24 mg) delivered a mean HbA1c reduction of 2.65% over 48 weeks, with 90% of patients reaching an HbA1c level of 6.5% or lower—a threshold for T2D management—and 62% achieving normoglycemia (HbA1c < 5.7%). In patients with poor baseline glycemic control (HbA1c > 8.5%), the 24 mg dose produced a 4.13% reduction at week 48. Weight loss was substantial, with a mean 15.5% reduction in body weight without a plateau. The safety profile remained consistent with other incretin-based therapies, featuring low discontinuation rates (2.0% in enicepatide arms vs. 0% in placebo) and no new safety signals.
Roche is advancing enicepatide through late-stage development, including two ongoing Phase III trials in chronic weight management (ENITH-1 and ENITH-2) and plans to initiate Phase III glycemic-control and cardiovascular trials in the first half of 2027. The drug’s mechanism—dual receptor activation with minimized receptor desensitization—positions it as a potential best-in-class candidate for metabolic disease management.
The study (CT-388-104, NCT06628362) enrolled 447 participants with T2D and obesity, evaluating efficacy, safety, and tolerability over 48 weeks. Enicepatide’s differentiated profile—combining glucose control and weight loss—could address unmet needs in cardiometabolic care, where obesity and diabetes drive significant global health burdens, including cardiovascular risks and complications like hypertension and neuropathy.
