Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Biomea Fusion Inc. · Industry
Who this trial is looking for
This trial is looking for adults with Type 2 Diabetes who are not reaching their blood sugar goals while using Ozempic. Participants will take icovamenib to see if it helps improve their condition.
Are You a Good Fit for This Trial?
Must be takingOzempic
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with Type 2 Diabetes.
I have been using Ozempic for at least 3 months.
I have an HbA1c between 7.5% and 9.5%.
I have a BMI between 25 and 40 kg/m2.
I am willing to provide signed consent to participate.
If I am female and of childbearing potential, I have a negative pregnancy test.
You may not be able to join if
I have Type 1 Diabetes.
I have had diabetic ketoacidosis in the last 6 months.
I have experienced severe hypoglycemia in the last 6 months.
I have a family history of certain types of thyroid cancer.
I have used certain diabetes medications in the last 3 months.
My fasting blood glucose is 240 mg/dL or higher.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 GLP-1-based therapy.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Males or females, age ≥18 years and ≤75 years
2. Have been diagnosed with T2D
3. 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…
Key Inclusion Criteria:
1. Males or females, age ≥18 years and ≤75 years
2. Have been diagnosed with T2D
3. 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) with a stable dose of all medications for at least 3 months prior to screening
4. Have HbA1c ≥7.0 and ≤10.5%
5. Have a BMI 25 to 45 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 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 agonists, amylin, or insulin
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