Zenagamtide for T2D nabs phase II win

In the treatment of patients with type 2 diabetes (T2D), the investigational zenagamtide helps improve glucose control, while having a safety and tolerability profile consistent with other GLP-1 and amylin receptor agonists, according to a dose-ranging phase II study.

Conducted at multiple centres across 11 countries, the trial included 186 adults with T2D who had HbA_1c levels of between 7 percent and 10 percent, had received stable doses of metformin with or without an SGLT2 inhibitor, and had a BMI of between 23 and 49 kg/m².

The patients were randomly assigned to receive zenagamtide 6 (n=54), 25 (n=51), or 50 mg (n=51) or placebo (n=30). Treatment was administered orally once daily for 36 weeks. The starting dose of oral zenagamtide was 15 mg, with dose escalations performed every 4 weeks until the maintenance dose was reached. All patients underwent a 4-week follow-up evaluation after the double-blind treatment period.

Compared with placebo, zenagamtide was associated with significant reductions in the primary outcome of HbA_1c at week 36. The estimated mean treatment differences were −0.5 percent with zenagamtide 6 mg (p=0.033), −0.99 percent with 25 mg (p=0.0001), and −1.09 percent with 50 mg (p<0.0001).

The most common adverse events (AEs) were gastrointestinal, occurring in 26 percent of participants in the zenagamtide 6-mg group, 41 percent in the 25-mg group, 47 percent in the 50-mg group, and 23 percent in the placebo group. Serious AEs were documented in 4 percent of zenagamtide-treated participants overall. There were no deaths reported during the trial.