Roche diabetes and obesity drug meets phase 2 goal, raising hopes for best-in-class potential

Roche’s dual GLP-1/GIP receptor agonist met the primary endpoint in a phase 2 trial involving patients with type 2 diabetes.

According to Fierce Biotech on the 22nd local time, Roche announced the phase 2 results for its candidate enicifaptide that day. The drug is an asset Roche acquired from Carmot Therapeutics in a $2.7 billion acquisition (approximately 3.6 trillion won).

Enicifaptide acts on the same targets as tirzepatide, which Eli Lilly markets as Mounjaro and Zepbound. Roche said its dual-bias mechanism differentiates the drug and is expected to extend its duration of action.

Among patients who received the highest dose, 24 mg weekly for 48 weeks, glycated hemoglobin (HbA1c), a blood glucose measure, fell by 2.65 percentage points. Roche cited this result as evidence of the drug’s potential to be best in class for the indication.

For comparison, Lilly’s Mounjaro reduced HbA1c by up to 1.8 percentage points at week 40 in a phase 3 trial, while the triple agonist retatrutide reduced it by up to 1.94 percentage points. Novo Nordisk’s Ozempic reduced HbA1c by 1.6 percentage points at week 30.

However, direct comparisons are difficult because Roche assessed the outcome 8 weeks later than Lilly. Despite this limitation, up to 90% of patients receiving enicifaptide achieved an HbA1c of 6.5% or less, exceeding retatrutide’s maximum of 85%.

The gap was wider for achieving an HbA1c of 5.7% or less: 62% with enicifaptide versus 46% with retatrutide. For weight loss, the mean reduction at week 48 in the high-dose group was 15.5%, and Roche said the decline occurred “without a clear plateau.”

Lilly reported a maximum weight loss of 15.3% for retatrutide at week 40. Roche has not yet released detailed safety and tolerability data, but, consistent with drugs in the same class, most gastrointestinal adverse events were mild to moderate.

Two percent of patients discontinued treatment because of adverse events, compared with 0% in the placebo group. In July, BMO Capital Markets analysts said enicifaptide’s weight-loss effect was meaningful but assessed that “Lilly’s retatrutide is likely to remain the preferred high-efficacy weight-loss drug for the time being.”

Roche is pursuing a broad phase 3 program with the goal of becoming one of the “top three companies” in obesity. It is conducting three late-stage trials in obesity—two global studies and one in China—and plans to begin phase 3 trials of glycemic control and cardiovascular outcomes in the first half of next year.