Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

Inclusion criteria

• Males or females, age ≥18 years and ≤75 years
• Diagnosed with T2D
• Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose 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 HbA1c ≥7.5 and ≤10.5%
• Have a BMI ≤32 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, and 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 positive GAD autoantibody result within 60 days 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
• Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
• Have fasting triglyceride ≥500 mg/dL
• Have an eGFR \<60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
• Have impaired liver function, defined as screening AST or ALT \>1.2×ULN, and/or total bilirubin \>ULN