[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase II results for dual GLP-1/GIP receptor agonist enicepatide in people living with type 2 diabetes and overweight or obesity

Basel, 22 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced positive topline results from CT-388-104, a Phase II clinical trial evaluating enicepatide (CT-388), an investigational, once-weekly dual GLP-1/GIP receptor agonist, in adults living with type 2 diabetes (T2D) and overweight or obesity. In the study, enicepatide met both primary endpoints, delivering dose-dependent and clinically meaningful reductions in blood glucose and body weight at 48 weeks. Patients receiving the highest titrated dose (24 mg) achieved an HbA1c reduction of 2.65% (from a baseline HbA1c of 8.1%). Furthermore, 90% of patients in the 24 mg cohort reached an HbA1c level of ≤6.5% (diagnostic threshold for T2D) and 62% achieved normoglycemia (HbA1c < 5.7%), restoring blood glucose levels to a non-diabetic range. The mean weight loss at 48 weeks in the 24 mg enicepatide arm was 15.5% without a demonstrable plateau.