Roche reported positive Phase II results Tuesday for enicepatide, an experimental drug targeting Type 2 diabetes and obesity. Enicepatide belongs to a newer class of therapies acting on both GLP-1 and GIP receptors.
In the trial, patients receiving the highest dose saw their long-term blood sugar marker (HbA1c) fall by an average of 2.65 percentage points, starting from a baseline of 8.1%. The same group shed an average of 15.5% of body weight over 48 weeks.
The effect was most pronounced among patients whose blood sugar was poorly controlled at the start of the study. Their HbA1c dropped by 4.13 percentage points. After 48 weeks, 90% of participants on the highest dose had reached an HbA1c of 6.5% or below, and 62% fell below 5.7%, into the normal range.
Roche said it does not draw direct comparisons with competitors' drugs, citing limitations inherent in comparing results across different studies. However, the company noted that historically, comparable HbA1c reductions for treatments starting at a baseline of 8.1% have typically ranged from 1.7 to 2.4 percentage points. Roche described enicepatide as showing particular promise for blood-sugar control but stressed that the findings must still be confirmed in larger Phase III trials.
The weight-loss result was lower than in an earlier Roche study of enicepatide conducted in people with overweight or obesity who did not have Type 2 diabetes. The company attributed the difference to a well-known pattern: people with Type 2 diabetes typically lose less weight on these therapies than those without diabetes. Roche added, however, that a 15.5% weight loss in Type 2 diabetes patients usually takes 72 weeks or longer to achieve in other studies, and that the weight-loss curve had not yet plateaued at the 48-week mark. Whether further weight loss would follow can only be determined in Phase III, the company said.
Roche said the safety profile of enicepatide was consistent with other drugs in the same class. Adverse events were mostly mild to moderate gastrointestinal symptoms, and only 2% of participants in the enicepatide groups discontinued treatment because of them.
Enicepatide is not yet approved. Roche plans to begin Phase III trials on blood-sugar control and cardiovascular outcomes in the first half of 2027. Two ongoing Phase III studies focused on weight reduction are already underway.
