NCT07502495 · Biomea Fusion Inc.
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
What this study is about
This is a Phase 2, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment trial assessing the effectiveness and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Birmingham, Alabama
- Canoga Park, California
- Long Beach, California
- Montclair, California
- San Diego, California
- Fort Myers, Florida
- Miami Lakes, Florida
- Winter Park, Florida
- Cordele, Georgia
- Las Vegas, Nevada
- Canton, Ohio
- Austin, Texas
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations