Clinical trial
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
Recruiting now · Phase 2 · 1 countries · Registry ID NCT07502508
Recruiting nowPhase 2Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes
Full registry 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
Treatments and study arms
icovamenib 100 mg
Drug
icovamenib 100 mg
Placebo
Drug
Matching placebo
Primary outcomes
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control26 weeks
Mean change in HbA1c from baseline
Study locations
17 locations were listed when this page was built. The first 40 are shown.
Elligo Health Research, Inc.🇺🇸 Austin, Texas, United States
Central Research Associates, LLC dba Flourish Research🇺🇸 Birmingham, Alabama, United States
Burke Internal Medicine and Research🇺🇸 Burke, Virginia, United States
Hope Clinical Research🇺🇸 Canoga Park, California, United States
Diabetes and Endocrinology Associates of Stark County🇺🇸 Canton, Ohio, United States
David Kavtaradze MD, Inc🇺🇸 Cordele, Georgia, United States
Zenos Clinical Research🇺🇸 Dallas, Texas, United States
Southwest General Healthcare Center🇺🇸 Fort Myers, Florida, United States
Synergy Group Medical🇺🇸 Houston, Texas, United States
Excel Clinical Research🇺🇸 Las Vegas, Nevada, United States
Epic Clinical Research🇺🇸 Lewisville, Texas, United States
Ark Clinical Research🇺🇸 Long Beach, California, United States
Panax Clinical Research🇺🇸 Miami Lakes, Florida, United States
Catalina Research Institute, LLC🇺🇸 Montclair, California, United States
Diabetes & Glandular Disease Clinic, P.A.🇺🇸 San Antonio, Texas, United States
Paradigm Clinical Research Centers, LLC🇺🇸 San Diego, California, United States
Flourish Research Orlando🇺🇸 Winter Park, Florida, United States