Type 2 Diabetes study: Icovamenib
Official title Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
ClinicalTrials.gov ID: NCT07502508
What this study is testing
What is icovamenib 100 mg?
This is an investigational medicine being studied to help lower blood sugar in people with 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 study is testing whether icovamenib helps lower blood sugar. It also checks how safe the drug is.
- Who it's for
- You may be able to join if you have type 2 diabetes. Your blood sugar must be high despite using GLP-1 therapy.
- What's involved
- You would take a daily pill. You would get the real drug or a pretend one by chance.
- Time commitment
- The study lasts for a set time with regular check-ins.
- 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 75
You may be able to join if
- Males or females, age ≥18 years and ≤75 years
- Have been diagnosed with T2D
- Taking FDA-approved GLP-1 based therapy (administered as subcutaneous injection) and have been treated with lifestyle management and 0 to 2...
- Have HbA1c ≥7.0 and ≤10.5%
- Have a BMI 25 to 45 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 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 MEN1 or MEN2 or medullary thyroid carcinoma
- Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones...
See the full eligibility criteria
- Males or females, age ≥18 years and ≤75 years
- Have been diagnosed with T2D
- Taking FDA-approved GLP-1 based therapy (administered as subcutaneous injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor)...
- Have HbA1c ≥7.0 and ≤10.5%
- Have a BMI 25 to 45 kg/m2
- 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...
- Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Key
- 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 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 MEN1 or MEN2 or medullary thyroid carcinoma
- Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2...
The study team makes the final eligibility decision.
Where it is enrolling
- 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
- Columbus, Georgia, United States
- Cordele, Georgia, United States
- Las Vegas, Nevada, United States
- Morehead City, North Carolina, United States
- Canton, Ohio, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Lewisville, Texas, United States
- Missouri City, Texas, United States
- San Antonio, Texas, United States
- Burke, 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, but 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at 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 14 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.