Oral Elecoglipron Trial Reports Glycemic And Weight Loss Gains

Key Takeaways

• Elecoglipron was associated with greater HbA1c reductions than placebo after 26 weeks.
• Once-daily oral elecoglipron was evaluated in a phase 2b, randomized, double-blind, placebo-controlled trial, with an additional open-label oral semaglutide arm.
• Safety and tolerability were generally consistent with the GLP-1 receptor agonist class, supporting continued phase 3 development.

At 26 weeks, adults with type 2 diabetes taking oral elecoglipron, a GLP-1 receptor agonist, showed greater reductions in HbA1c than placebo. Elecoglipron is a once-daily oral, small-molecule GLP-1 receptor agonist in development for the management of type 2 diabetes.

The SOLSTICE trial was a multicenter, phase 2b, randomized, double-blind, placebo-controlled study of elecoglipron in 406 adults with type 2 diabetes across nine countries, including the United States. Participants were randomly assigned across treatment groups designed to test a range of starting doses, escalation approaches, and maintenance doses. The trial also included an open-label oral semaglutide comparator arm. This 26-week readout came from a dose-ranging phase 2b development program rather than a later confirmatory trial.

After 26 weeks, investigators found that elecoglipron lowered HbA1c more than placebo across all tested doses. Mean HbA1c reductions ranged from −0.91% (95% CI, −1.25 to −0.58) with the 5-mg dose to −1.88% (95% CI, −2.23 to −1.53) with the 75-mg dose using every-2-week dose escalation, compared with −0.15% (95% CI, −0.42 to 0.12) with placebo. The dose-ranging design compared glycemic responses across multiple oral treatment strategies within the same study.

Researchers described safety and tolerability as generally consistent with the GLP-1 receptor agonist class at a similar stage of development. Adverse events were reported in 63% to 87% of participants receiving elecoglipron, compared with 63% of those receiving placebo. The most common adverse events were gastrointestinal, including nausea, constipation, diarrhea, and vomiting. Elecoglipron was administered once daily without food or fluid restrictions.

The investigators concluded that the findings support continued development with phase 3 trials for people living with type 2 diabetes.