Actively Recruiting
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
Led by Biomea Fusion Inc. · Updated on 2026-05-12
60
Participants Needed
16
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females, age 18 years to 70 years
- Diagnosed with Type 2 Diabetes
- Currently on lifestyle management plus 1 to 3 stable antihyperglycemic medications: metformin, SGLT2 inhibitors, alogliptin, or sitagliptin for at least 3 months (metformin dose at least 500 mg/day)
- Have HbA1c between 7.5% and 10.5%
- Have a body mass index (BMI) of 32 kg/m2 or less
- Female participants of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to have pregnancy tests during the study
- Willing and able to provide informed consent and comply with study procedures and tests
You will not qualify if you...
- Have type 1 diabetes mellitus or any secondary form of diabetes
- History of diabetic ketoacidosis or hyperosmolar coma within 6 months before screening
- Positive GAD autoantibody at screening
- History of severe hypoglycemia requiring assistance or hypoglycemia unawareness within 6 months before screening
- Personal or first-degree family history of MEN1
- Use of GLP-1 receptor agonists, dual GIP/GLP-1 receptor agonists, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitors, DPP4 inhibitors (linagliptin, saxagliptin), bile acid sequestrants, dopamine-2 agonists, amylin, or insulin within 3 months before screening
- Fasting plasma glucose (FPG) equal or above 240 mg/dL
- Fasting triglycerides equal or above 500 mg/dL
- Estimated glomerular filtration rate (eGFR) below 75 mL/min/1.73 m2
- Impaired liver function with AST or ALT above 1.2 times upper limit of normal or total bilirubin above upper limit of normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Hope Clinical Research
Canoga Park, California, United States, 91303
Actively Recruiting
3
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
4
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Actively Recruiting
5
Paradigm Clinical Research Centers, LLC
San Diego, California, United States, 92108
Actively Recruiting
6
Southwest General Healthcare Center
Fort Myers, Florida, United States, 33907
Actively Recruiting
7
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Actively Recruiting
8
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States, 32789
Actively Recruiting
9
David Kavtaradze MD, Inc
Cordele, Georgia, United States, 31015
Actively Recruiting
10
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Actively Recruiting
11
Diabetes and Endocrinology Associates of Stark County
Canton, Ohio, United States, 44718
Actively Recruiting
12
Elligo Health Research, Inc.
Austin, Texas, United States, 78704
Actively Recruiting
13
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
14
Synergy Groups Medical
Houston, Texas, United States, 77061
Actively Recruiting
15
Epic Clinical Research
Lewisville, Texas, United States, 75057
Actively Recruiting
16
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Actively Recruiting
Research Team
B
Biomea Fusion Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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