NCT07502495 Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
| NCT ID | NCT07502495 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Biomea Fusion Inc. |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-03-27 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07502495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07502495 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07502495 currently recruiting?
Yes, NCT07502495 is actively recruiting participants. Contact the research team at clinicaltrials@biomeafusion.com for enrollment information.
Where is the NCT07502495 trial being conducted?
This trial is being conducted at Birmingham, United States, Canoga Park, United States, Long Beach, United States, Montclair, United States and 11 additional locations.
Who is sponsoring the NCT07502495 clinical trial?
NCT07502495 is sponsored by Biomea Fusion Inc.. The trial plans to enroll 60 participants.
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