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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
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 (17)
Facility
City
Region
Status
Central Research Associates, LLC dba Flourish Research
Birmingham
Alabama
Recruiting
Hope Clinical Research
Canoga Park
California
Recruiting
Ark Clinical Research
Long Beach
California
Recruiting
Catalina Research Institute, LLC
Montclair
California
Recruiting
Paradigm Clinical Research Centers, LLC
San Diego
California
Recruiting
Southwest General Healthcare Center
Fort Myers
Florida
Recruiting
Panax Clinical Research
Miami Lakes
Florida
Recruiting
Flourish Research Orlando
Winter Park
Florida
Recruiting
David Kavtaradze MD, Inc
Cordele
Georgia
Recruiting
Excel Clinical Research
Las Vegas
Nevada
Recruiting
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.