This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy.
Males or females, age ≥18 years and ≤70 years
Have been diagnosed with T2D
Taking Ozempic (semaglutide injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with a stable dose of all medications for at least 3 months prior to screening
If participants are taking metformin, they must be on a minimum stable dose of ≥500 mg/day
Have type 1 diabetes mellitus or a secondary form of diabetes
Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator
Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma