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NCT07502508PHASE2Recruiting

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy

Biomea Fusion Inc.

Start Date

4/30/2026

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 (T2D) not achieving glycemic targets despite Ozempic-based therapy.

Detailed Description

This study is a 52-week, phase 2 trial designed to examine whether treatment with icovamenib in participants with T2D who are currently on an Ozempic-based therapy will result in a greater reduction in HbA1c than Ozempic-based therapy alone. The current trial investigates participants who have used Ozempic for at least 3 months prior to screening whose HbA1c remains above the target established by the ADA.

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

DRUG

icovamenib 100 mg

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

Flourish Research Orlando

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 Group Medical

Houston, Texas 77061

United States

Epic Clinical Research

Lewisville, Texas 75057

United States

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas 78229

United States

Burke Internal Medicine and Research

Burke, Virginia 22015

United States