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

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 (T2D) not achieving glycemic targets despite Ozempic-based therapy.

Eligibility

Inclusion Criteria:

1. Males or females, age ≥18 years and ≤70 years
2. Have been diagnosed with T2D
3. 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

   * Participants taking metformin must be on a minimum stable dose of ≥500 mg/day
   * Participants taking Ozempic must be on a minimum stable dose of ≥0.5 mg/week
4. Have HbA1c ≥7.5 and ≤9.5%
5. Have a BMI 25 to 40 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 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
4. Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
5. Use of GLP-1 RA other than Ozempic (semaglutide injection), dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
6. Have FPG ≥240 mg/dL

Conditions2

Interventions1

Locations14 sites

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