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

Key Inclusion Criteria:

1. Males or females, age ≥18 years and ≤75 years
2. Diagnosed with T2D
3. 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)
4. Have HbA1c ≥7.5 and ≤10.5%
5. Have a BMI ≤32 kg/m2
6. 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.
7. 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:

1. Have type 1 diabetes mellitus or a secondary form of diabetes
2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
3. Have positive GAD autoantibody result within 60 days prior to screening
4. 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
5. Have personal or family history (first-degree relative) of MEN1
6. 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
7. Have fasting triglyceride ≥500 mg/dL
8. Have an eGFR <60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
9. Have impaired liver function, defined as screening AST or ALT >1.2×ULN, and/or total bilirubin >ULN