Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy

Key Inclusion Criteria

• Males or females, age ≥18 years and ≤75 years
• Have been diagnosed with T2D
• Taking FDA-approved GLP-1 based therapy (administered as subcutaneous 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
• Have HbA1c ≥7.0 and ≤10.5%
• Have a BMI 25 to 45 kg/m2
• Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, must agree to the sex and contraception requirements.
• Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

Key Exclusion Criteria

• 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
• Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin