Roche's Enicepatide Hits Both Phase II Endpoints in Type 2 Diabetes and Obesity

โดย Zacks Investment Research·EUCH·Read original
Summary · why it matters

Roche reported encouraging top-line results from a mid-stage study of enicepatide, its investigational once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes and overweight or obesity. In the 447-patient phase II CT-388-104 study, enicepatide met both primary endpoints at 48 weeks, delivering dose-dependent reductions in HbA1c and body weight. At the highest titrated dose of 24 mg, enicepatide reduced HbA1c by 2.65% from a baseline of 8.1%, with about 90% of patients achieving an HbA1c of 6.5% or lower and 62% reaching normoglycemia below 5.7%, while mean body-weight loss was 15.5% at 48 weeks with no evidence of a plateau. In patients with poor baseline glycemic control above 8.5%, the 24 mg dose led to an HbA1c reduction of 4.13% at 48 weeks, and the drug was generally well tolerated with discontinuations due to adverse events of 2.0% in the enicepatide groups versus 0% for placebo. Roche is advancing two ongoing phase III studies in chronic weight management, ENITH-1 and ENITH-2, and plans to initiate a phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027. Separately, Roche announced that the European Commission has approved Susvimo, a ranibizumab 100 mg/mL solution for injection, for the treatment of neovascular age-related macular degeneration, making it the first and only continuous-delivery treatment approved for nAMD in Europe.

Impact on assets 3

Biotech & Genomic Medicine▼ · 2 stocks
Eli Lilly and Company
LLY
▼ NegativeCompetitionrelevance

Roche's enicepatide hits both phase II endpoints in type 2 diabetes and obesity, intensifying competition in the GLP-1/GIP obesity space where Eli Lilly competes.

Novo Nordisk A/S
NOV
▼ NegativeCompetitionrelevance

Positive phase II data for Roche's dual GLP-1/GIP agonist enicepatide signals a new rival in the obesity/diabetes market Novo Nordisk dominates.

Health Care▲ · 1 stocks
Roche Holding AG
ROP
▲ PositiveTechnologyRegulationrelevance

Roche's enicepatide met both primary endpoints in phase II with strong HbA1c and weight reductions, advancing its obesity/diabetes pipeline.

Theme Impact 1

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