RecruitingPhase 2NCT07502495
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
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.
Enrollment
60 participants
Start Date
Mar 27, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria7
- Males or females, age ≥18 years and ≤70 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 (participants taking metformin 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 and must be willing to have additional pregnancy tests during the study.
- Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
Exclusion Criteria9
- 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 at 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 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
- Have FPG ≥240 mg/dL
- Have fasting triglyceride ≥500 mg/dL
- Have an eGFR <75 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
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Interventions
DRUGicovamenib 100mg
icovamenib 100mg
DRUGPlacebo
Matching placebo
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07502495
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