Roche Phase II: weekly dual GLP-1/GIP drug enicepatide cuts HbA1c and weight in type 2 diabetes
On 22 September 2026 Roche reported topline Phase II results for once-weekly enicepatide (CT-388) in 447 adults with type 2 diabetes and overweight or obesity: at 24 mg, mean HbA1c fell 2.65% and mean weight loss was 15.5% at 48 weeks. Phase III programs are planned.
Swiss drugmaker Roche announced positive topline results on 22 September 2026 from CT-388-104, a randomised, double-blind, placebo-controlled Phase II trial of enicepatide (CT-388), an investigational once-weekly dual GLP-1/GIP receptor agonist, in 447 adults with type 2 diabetes and overweight or obesity. Both primary endpoints — change in HbA1c and body weight at week 48 — were met with dose-dependent effects, according to the company and Reuters.
Key numbers from the highest dose
At the highest titrated dose (24 mg), Roche reported a mean HbA1c reduction of 2.65% from a baseline of 8.1%. About 90% of that cohort reached HbA1c ≤6.5%, and 62% reached normoglycemia (HbA1c <5.7%). Mean weight loss was 15.5% at 48 weeks without a reported plateau. In patients with baseline HbA1c >8.5%, the company said the 24 mg arm saw a 4.13% HbA1c drop. Discontinuation for adverse events was 2.0% on enicepatide versus 0% on placebo; gastrointestinal effects were mostly mild to moderate, consistent with the incretin class. No new safety signals were identified in the topline release.
What comes next — and limits
Roche is running Phase III weight-management studies (ENITH-1 and ENITH-2) and plans to start Phase III glycemic-control and cardiovascular outcomes trials in the first half of 2027. These are Phase II topline results from a company release, not a full peer-reviewed manuscript; longer-term and comparative outcomes versus marketed dual agonists remain to be shown in larger trials. This summary is not personal medical advice — talk to a clinician about individual treatment options.
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