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New treatment option for Type 2 Diabetes
Official title Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
ClinicalTrials.gov ID: NCT07502495
What this study is testing
What is icovamenib 100mg?
icovamenib 100mg is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Males or females, age ≥18 years and ≤70 years
- Diagnosed with T2D
- Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable...
- Have HbA1c ≥7.5 and ≤10.5%
- Have a BMI ≤32 kg/m2
You likely can't join if
- Have type 1 diabetes mellitus or a secondary form of diabetes
- Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
- Have positive GAD autoantibody result at screening
- Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in...
- Have personal or family history (first-degree relative) of MEN16. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides...
- Have FPG ≥240 mg/dL
See the full eligibility criteria
- Males or females, age ≥18 years and ≤70 years
- Diagnosed with T2D
- 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 (participants taking...
- Have HbA1c ≥7.5 and ≤10.5%
- Have a BMI ≤32 kg/m2
- 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.
- Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
- Have type 1 diabetes mellitus or a secondary form of diabetes
- Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
- Have positive GAD autoantibody result at screening
- 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...
- Have personal or family history (first-degree relative) of MEN16. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, [linagliptin, saxagliptin (these 2 are...
- Have FPG ≥240 mg/dL
- Have fasting triglyceride ≥500 mg/dL
- Have an eGFR \<75 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
- Have impaired liver function, defined as screening AST or ALT \>1.2×ULN, and/or total bilirubin \>ULN
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Canoga Park, California, United States
- Long Beach, California, United States
- Montclair, California, United States
- San Diego, California, United States
- Fort Myers, Florida, United States
- Miami Lakes, Florida, United States
- Winter Park, Florida, United States
- Cordele, Georgia, United States
- Las Vegas, Nevada, United States
- Canton, Ohio, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Lewisville, Texas, United States
- Manassas, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Canoga Park, California, United States; Long Beach, California, United States; Montclair, California, United States; San Diego, California, United States; Fort Myers, Florida, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.