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

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.

Eligibility

Inclusion Criteria:

1. Males or females, age ≥18 years and ≤70 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 (participants taking metformin 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 and must be willing to have additional pregnancy tests during the study.
7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

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 at 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 MEN16. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP4I class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
6. Have FPG ≥240 mg/dL
7. Have fasting triglyceride ≥500 mg/dL
8. Have an eGFR \<75 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

Conditions2

Interventions1

Locations15 sites

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