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NCT07502495PHASE2Recruiting

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

Biomea Fusion Inc.

Start Date

3/27/2026

Completion Date

7/1/2027

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.

Detailed Description

This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (ADA).

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

DRUG

icovamenib 100mg

DRUG

Placebo

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Conditions

Type 2 Diabetes

Locations

Central Research Associates, LLC dba Flourish Research

Birmingham, Alabama 35205

United States

Hope Clinical Research

Canoga Park, California 91303

United States

Ark Clinical Research

Long Beach, California 90815

United States

Catalina Research Institute, LLC

Montclair, California 91763

United States

Paradigm Clinical Research Centers, LLC

San Diego, California 92108

United States

Southwest General Healthcare Center

Fort Myers, Florida 33907

United States

Panax Clinical Research

Miami Lakes, Florida 33014

United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida 32789

United States

David Kavtaradze MD, Inc

Cordele, Georgia 31015

United States

Excel Clinical Research

Las Vegas, Nevada 89109

United States

Diabetes and Endocrinology Associates of Stark County

Canton, Ohio 44718

United States

Elligo Health Research, Inc.

Austin, Texas 78704

United States

Zenos Clinical Research

Dallas, Texas 75230

United States

Synergy Groups Medical

Houston, Texas 77061

United States

Epic Clinical Research

Lewisville, Texas 75057

United States

Manassas Clinical Research Center

Manassas, Virginia 20110

United States