Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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
Study sites (17)
AL
- Central Research Associates, LLC dba Flourish Research · Birmingham, AL 35205More trials in Birmingham
CA
- Hope Clinical Research · Canoga Park, CA 91303More trials in Canoga Park
- Ark Clinical Research · Long Beach, CA 90815More trials in Long Beach
- Catalina Research Institute, LLC · Montclair, CA 91763More trials in Montclair
- Paradigm Clinical Research Centers, LLC · San Diego, CA 92108More trials in San Diego
FL
- Southwest General Healthcare Center · Fort Myers, FL 33907More trials in Fort Myers
- Panax Clinical Research · Miami Lakes, FL 33014More trials in Miami Lakes
- Flourish Research Orlando · Winter Park, FL 32789More trials in Winter Park
GA
- David Kavtaradze MD, Inc · Cordele, GA 31015More trials in Cordele
NV
- Excel Clinical Research · Las Vegas, NV 89109More trials in Las Vegas
OH
- Diabetes and Endocrinology Associates of Stark County · Canton, OH 44718More trials in Canton
TX
- Elligo Health Research, Inc. · Austin, TX 78704More trials in Austin
- Zenos Clinical Research · Dallas, TX 75230More trials in Dallas
- Synergy Group Medical · Houston, TX 77061More trials in Houston
- Epic Clinical Research · Lewisville, TX 75057More trials in Lewisville
- Diabetes & Glandular Disease Clinic, P.A. · San Antonio, TX 78229More trials in San Antonio
VA
- Burke Internal Medicine and Research · Burke, VA 22015More trials in Burke