Tests icovamenib in adults with type 2 diabetes not reaching blood sugar goals
Tests icovamenib against placebo in adults with type 2 diabetes on GLP-1 therapy.
Plain-language title generated from the registry record
Registry title: Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
Key facts
- Where
- Austin, Birmingham, Burke, Canoga Park, Canton, Columbus, Cordele, Dallas, Fort Myers, Houston, Las Vegas, Lewisville, Long Beach, Miami Lakes, Missouri City, Montclair, Morehead City, San Antonio, San Diego, and Winter Park, United StatesSee the 20 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07502508, who can take part
Where in United States
- Elligo Health Research, Inc.Austin, United StatesTaking people
- Central Research Associates, LLC dba Flourish ResearchBirmingham, United StatesTaking people
- Burke Internal Medicine and ResearchBurke, United StatesTaking people
- Hope Clinical ResearchCanoga Park, United StatesTaking people
- Diabetes and Endocrinology Associates of Stark CountyCanton, United StatesTaking people
- Centricity Research, Endocrine Consultants PCColumbus, United StatesTaking people
- David Kavtaradze MD, Inc.Cordele, United StatesTaking people
- Zenos Clinical ResearchDallas, United StatesTaking people
- Southwest General Healthcare CenterFort Myers, United StatesTaking people
- Synergy Group MedicalHouston, United StatesTaking people
- Excel Clinical ResearchLas Vegas, United StatesTaking people
- Epic Clinical ResearchLewisville, United StatesTaking people
- Ark Clinical ResearchLong Beach, United StatesTaking people
- Panax Clinical ResearchMiami Lakes, United StatesTaking people
- Synergy Group MedicalMissouri City, United StatesTaking people
- Catalina Research Institute, LLCMontclair, United StatesTaking people
- Centricity Research, Lucas Research, Inc.Morehead City, United StatesTaking people
- Diabetes & Glandular Disease Clinic, P.A.San Antonio, United StatesTaking people
- Paradigm Clinical Research Centers, LLCSan Diego, United StatesTaking people
- Flourish Research OrlandoWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biomea Fusion Inc.
- Trial code
- NCT07502508
- Record updated
- 20 October 2026
- Original 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 (T2D) not achieving glycemic targets despite GLP-1-based therapy.Read full original descriptionShow less
Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy
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 GLP-1-based therapy.
Inclusion: Males or females, age ≥18 years and ≤75 years; Have been diagnosed with T2D; Taking FDA-approved GLP-1 based therapy (administered as subcutaneous 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; Have HbA1c ≥7.0 and ≤10.5%; Have a BMI 25 to 45 kg/m2; 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; Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
Exclusion: Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to 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; Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin; Have type 1 diabetes mellitus or a secondary form of diabetes; Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma.