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Clinical Trials in the USA / NCT07502495
Active, not recruiting Phase 2

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

NCT07502495 · tracked via the Priya Life Science USA tracker
Sponsor
Biomea Fusion Inc.
Phase
Phase 2
Started
2026-03-27
Last updated
2026-08-28

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

icovamenib 100mg →Placebo

icovamenib 100mg: icovamenib 100mg

Placebo: Matching placebo

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Males or females, age ≥18 years and ≤75 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 (if participants are taking metformin they 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, must be willing to have additional pregnancy tests during the study, and 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 positive GAD autoantibody result within 60 days prior to 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 MEN1 6. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening 7. Have fasting triglyceride ≥500 mg/dL 8. Have an eGFR \<60 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

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Central Research Associates, LLC dba Flourish Research Birmingham Alabama
Hope Clinical Research Canoga Park California
Ark Clinical Research Fountain Valley California
Ark Clinical Research Long Beach California
Catalina Research Institute, LLC Montclair California
Paradigm Clinical Research Centers, LLC San Diego California
Southwest General Healthcare Center Fort Myers Florida
Panax Clinical Research Miami Lakes Florida
Clinical Site Partners, LLC dba Flourish Research Winter Park Florida
David Kavtaradze MD, Inc Cordele Georgia
Excel Clinical Research Las Vegas Nevada
Diabetes and Endocrinology Associates of Stark County Canton Ohio
Elligo Health Research, Inc. Austin Texas
Zenos Clinical Research Dallas Texas
Synergy Groups Medical Houston Texas
Epic Clinical Research Lewisville Texas
Synergy Group Medical LLC Missouri City Texas
Manassas Clinical Research Center Manassas Virginia

More Biomea Fusion Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07502495 on ClinicalTrials.gov ↗ ← All trials in the USA