Enrolling now · NCT07502508

A study testing whether icovamenib from Biomea Fusion, an investigational diabetes medicine, can lower blood sugar and help with weight.

Who can join
Adults 18 to 70, have type 2 diabetes, BMI 25+.
What you take
icovamenib 100 mg, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
How long it lasts
The study runs about 15 months.
What you get
The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
Phase Phase 2Sponsor Biomea Fusion Inc.Drug icovamenib 100 mgClass OtherSites 16 USEnrollment target 60

What this study is for

Full study title: Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based The.

Primary condition: Type 2 Diabetes.

Who can join, in detail

Age 18 to 70
Sex All
BMI 25 to 40

Key inclusion criteria

  • Males or females, age >=18 years and <=70 years
  • Have been diagnosed with T2D
  • 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
  • Participants taking metformin must be on a minimum stable dose of >=500 mg/day
  • Participants taking Ozempic must be on a minimum stable dose of >=0.5 mg/week

Key exclusion criteria

  • Have type 1 diabetes mellitus or a secondary form of diabetes
  • 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
  • Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
  • 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

Where this study is enrolling

This trial has 16 US sites across 8 states. Contact the site coordinator directly to start the screening process.

Alabama

  • Central Research Associates, LLC dba Flourish Research
    Birmingham, Alabama

California

  • Hope Clinical Research
    Canoga Park, California
  • Ark Clinical Research
    Long Beach, California
  • Catalina Research Institute, LLC
    Montclair, California
  • Paradigm Clinical Research Centers, LLC
    San Diego, California

Florida

  • Southwest General Healthcare Center
    Fort Myers, Florida
  • Panax Clinical Research
    Miami Lakes, Florida

Georgia

  • David Kavtaradze MD, Inc
    Cordele, Georgia

Nevada

  • Excel Clinical Research
    Las Vegas, Nevada

Ohio

  • Diabetes and Endocrinology Associates of Stark County
    Canton, Ohio

Texas

  • Elligo Health Research, Inc.
    Austin, Texas
  • Zenos Clinical Research
    Dallas, Texas
  • Synergy Group Medical
    Houston, Texas
  • Epic Clinical Research
    Lewisville, Texas
  • Diabetes & Glandular Disease Clinic, P.A.
    San Antonio, Texas

Virginia

  • Burke Internal Medicine and Research
    Burke, Virginia

Timeline

Started enrolling: 2026-04. Expected completion: 2027-07. Last updated on ClinicalTrials.gov: 2026-05-12.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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