RecruitingType 2 Diabetes
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
Eligible age
18–70 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Biomea Fusion Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07502495 · last updated 2026-05-12