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[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

RHHBY
  • Roche announced positive Phase II topline results for enicepatide (CT-388), a once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes & overweight/obesity
  • At the highest dose of 24 mg, enicepatide achieved a mean HbA1c reduction of 2.65% over 48 weeks with a baseline HbA1c of 8.1%
  • Patients with poor baseline glycemic control (HbA1c >8.5%) experienced a 4.13% HbA1c reduction at 48 weeks
  • 90% of patients in the 24 mg cohort reached the T2D glycemic target of ≤6.5% HbA1c, while 62% achieved normoglycemia (HbA1c <5.7%)
  • The 24 mg dose resulted in a mean weight loss of 15.5% at 48 weeks without a weight loss plateau
  • Safety & tolerability profiles were consistent with the incretin class, featuring low discontinuation rates of 2.0% & no new safety signals
  • The most common adverse events were predominantly mild-to-moderate gastrointestinal effects
  • Study CT-388-104 was a randomized, double-blind, placebo-controlled trial involving 447 adults evaluated over 48 weeks
  • Roche plans to initiate Phase III glycemic control programs & cardiovascular outcomes trials in the first half of 2027
  • Two ongoing Phase III studies in chronic weight management (ENITH-1 & ENITH-2) are currently advancing the drug development program