Roche posts positive Phase II diabetes data for enicepatide

Roche unit Genentech announced positive topline results on September 22, 2026, from the Phase II CT-388-104 clinical trial evaluating enicepatide in 447 adults living with type 2 diabetes and overweight or obesity. The investigational, once-weekly dual GLP-1/GIP receptor agonist met both primary endpoints at 48 weeks, showing dose-dependent reductions in blood glucose and body weight.

At the highest 24 mg dose, patients achieved a mean HbA1c reduction of 2.65% from a baseline of 8.1%. Among patients with baseline HbA1c above 8.5%, the 24 mg dose reduced HbA1c by 4.13%. Overall, 90% of patients in that group reached an HbA1c of 6.5% or lower, while 62% reached normoglycemia below 5.7%. Patients on the 24 mg regimen also achieved a mean weight loss of 15.5% at 48 weeks without reaching a plateau.

The drug showed a safety profile consistent with the incretin class. Most adverse events were mild-to-moderate gastrointestinal effects, and discontinuations due to adverse events stood at 2.0% across enicepatide arms compared with 0.0% on placebo.

Genentech has two Phase III trials underway in chronic weight management, named ENITH-1 and ENITH-2. The company plans to initiate a Phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027.