Condition: Type 2 Diabetes · Sponsor: Biomea Fusion Inc.
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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.
This description comes directly from the study's public registry record.
Biomea Fusion Inc. · 8442450490 · clinicaltrials@biomeafusion.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Key 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 * If participants are taking metformin, they must be on a minimum stable dose of ≥500 mg/day * Participants must be on a minimum stable dose of Ozempic ≥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, must be willing to have additional pregnancy tests during the study, must agree to the sex and contraception requirements. 7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Key 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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Central Research Associates, LLC dba Flourish Research | Birmingham, Alabama, United States | Recruiting |
| Hope Clinical Research | Canoga Park, California, United States | Recruiting |
| Ark Clinical Research | Long Beach, California, United States | Recruiting |
| Catalina Research Institute, LLC | Montclair, California, United States | Recruiting |
| Paradigm Clinical Research Centers, LLC | San Diego, California, United States | Recruiting |
| Southwest General Healthcare Center | Fort Myers, Florida, United States | Recruiting |
| Panax Clinical Research | Miami Lakes, Florida, United States | Recruiting |
| Flourish Research Orlando | Winter Park, Florida, United States | Recruiting |
| David Kavtaradze MD, Inc | Cordele, Georgia, United States | Recruiting |
| Excel Clinical Research | Las Vegas, Nevada, United States | Recruiting |
| Diabetes and Endocrinology Associates of Stark County | Canton, Ohio, United States | Recruiting |
| Elligo Health Research, Inc. | Austin, Texas, United States | Recruiting |
+ 5 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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