What this trial means for you
This study is recruiting now at 16 US sites. It's studying icovamenib 100 mg, Placebo for type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 * Participants taking metformin must be on a minimum stable dose of ≥500 mg/day * Participants taking Ozempic must be on a minimum stable dose of ≥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 and must be willing to have additional pregnancy tests during the study.7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. 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 by state
Alabama
- Central Research Associates, LLC dba Flourish Research — Birmingham · Recruiting now
California
- Hope Clinical Research — Canoga Park · Recruiting now
- Ark Clinical Research — Long Beach · Recruiting now
- Catalina Research Institute, LLC — Montclair · Recruiting now
- Paradigm Clinical Research Centers, LLC — San Diego · Recruiting now
Florida
- Southwest General Healthcare Center — Fort Myers · Recruiting now
- Panax Clinical Research — Miami Lakes · Recruiting now
Georgia
- David Kavtaradze MD, Inc — Cordele · Recruiting now
Nevada
- Excel Clinical Research — Las Vegas · Recruiting now
Ohio
- Diabetes and Endocrinology Associates of Stark County — Canton · Recruiting now
Texas
- Elligo Health Research, Inc. — Austin · Recruiting now
- Zenos Clinical Research — Dallas · Recruiting now
- Synergy Group Medical — Houston · Recruiting now
- Epic Clinical Research — Lewisville · Recruiting now
- Diabetes & Glandular Disease Clinic, P.A. — San Antonio · Recruiting now
Virginia
- Burke Internal Medicine and Research — Burke · Recruiting now
View the official record on ClinicalTrials.gov →
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