Actively Recruiting
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
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 (T2D) not achieving glycemic targets despite Ozempic-based therapy.
CONDITIONS
Official Title
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years
- Diagnosed with Type 2 Diabetes
- Taking Ozempic (semaglutide injection) with stable doses for at least 3 months
- Treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with stable doses
- Metformin dose at least 500 mg/day if used
- Ozempic dose at least 0.5 mg/week
- HbA1c between 7.5% and 9.5%
- Body Mass Index (BMI) between 25 and 40 kg/m2
- 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
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
- History of diabetic ketoacidosis or hyperosmolar coma within 6 months before screening
- History of severe hypoglycemia requiring assistance or poor recognition of hypoglycemic symptoms within 6 months before screening
- Personal or family history of MEN1, MEN2, or medullary thyroid carcinoma
- Use of GLP-1 receptor agonists other than Ozempic, dual GIP/GLP-1 receptor agonists, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitors, DPP4 inhibitors, bile acid sequestrants, dopamine-2 agonists, amylin, or insulin within 3 months before screening
- Fasting plasma glucose (FPG) equal to or above 240 mg/dL
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
David Kavtaradze MD, Inc
Cordele, Georgia, United States, 31015
Actively Recruiting
9
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Actively Recruiting
10
Diabetes and Endocrinology Associates of Stark County
Canton, Ohio, United States, 44718
Actively Recruiting
11
Elligo Health Research, Inc.
Austin, Texas, United States, 78704
Actively Recruiting
12
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
13
Synergy Group Medical
Houston, Texas, United States, 77061
Actively Recruiting
14
Epic Clinical Research
Lewisville, Texas, United States, 75057
Actively Recruiting
15
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States, 78229
Actively Recruiting
16
Burke Internal Medicine and Research
Burke, Virginia, United States, 22015
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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