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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. Males or females, age ≥18 years and ≤75 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 (if participants are taking metformin they 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, must be willing to have additional pregnancy tests during the study, and 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 positive GAD autoantibody result within 60 days prior to 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 MEN1
6. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
7. Have fasting triglyceride ≥500 mg/dL
8. Have an eGFR \<60 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
Primary outcome measure(s)
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control — 26 weeks Mean change in HbA1c from baseline
Trial sites (18)
Facility
City
Region
Status
Central Research Associates, LLC dba Flourish Research
Birmingham
Alabama
Hope Clinical Research
Canoga Park
California
Ark Clinical Research
Fountain Valley
California
Ark Clinical Research
Long Beach
California
Catalina Research Institute, LLC
Montclair
California
Paradigm Clinical Research Centers, LLC
San Diego
California
Southwest General Healthcare Center
Fort Myers
Florida
Panax Clinical Research
Miami Lakes
Florida
Clinical Site Partners, LLC dba Flourish Research
Winter Park
Florida
David Kavtaradze MD, Inc
Cordele
Georgia
Excel Clinical Research
Las Vegas
Nevada
Diabetes and Endocrinology Associates of Stark County
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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