Icovamenib for adults with type 2 diabetes who are not meeting blood sugar targets

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

This trial tests whether adding icovamenib to usual diabetes medicines helps lower HbA1c in adults with type 2 diabetes who are not reaching their blood sugar goals.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Biomea Fusion Inc. (Industry-sponsored)
• Locations: 16 sites (Birmingham, Alabama and 15 other locations)
• Trial ID: NCT07502495 on ClinicalTrials.gov

What this trial studies

This is a 52-week, randomized, double-blind, placebo-controlled Phase 2 trial comparing icovamenib 100 mg to placebo added to standard-of-care antihyperglycemic therapy. Eligible participants are adults 18–70 years with type 2 diabetes, HbA1c between 7.5% and 10.5%, BMI ≤32 kg/m2, and on a stable dose of metformin, an SGLT2 inhibitor, alogliptin, or sitagliptin for at least 3 months. The study measures changes in HbA1c and safety outcomes versus placebo while participants continue lifestyle management and their background medications. Participants are randomized to receive either icovamenib or matching placebo and are followed with scheduled visits and laboratory testing over the year.

Who should consider this trial

Good fit: Adults aged 18–70 with type 2 diabetes, HbA1c 7.5–10.5%, BMI ≤32 kg/m2, and on a stable dose of metformin, an SGLT2 inhibitor, alogliptin, or sitagliptin for at least 3 months are ideal candidates.

Not a fit: People with type 1 or secondary diabetes, recent diabetic ketoacidosis, positive GAD autoantibodies, BMI over 32, or those not on the allowed background medications or outside the age/HbA1c ranges are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, icovamenib could help more people with type 2 diabetes reach recommended HbA1c targets when current medications are not enough.

How similar studies have performed: Icovamenib is a novel compound with limited published human data, although other approved glucose-lowering drug classes have demonstrated benefit in similar patient populations.

Eligibility criteria

Inclusion Criteria:

1. Males or females, age ≥18 years and ≤70 years
2. Diagnosed with T2D
3. 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 metformin must be on a minimum stable dose of ≥500 mg/day)
4. Have HbA1c ≥7.5 and ≤10.5%
5. Have a BMI ≤32 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 positive GAD autoantibody result at screening
4. 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
5. 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, \[linagliptin, saxagliptin (these 2 are drugs within DPP4I class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
6. Have FPG ≥240 mg/dL
7. Have fasting triglyceride ≥500 mg/dL
8. Have an eGFR \<75 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
9. Have impaired liver function, defined as screening AST or ALT \>1.2×ULN, and/or total bilirubin \>ULN

Where this trial is running

Birmingham, Alabama and 15 other locations

• Central Research Associates, LLC dba Flourish Research — Birmingham, Alabama, United States (Recruiting)
• Hope Clinical Research — Canoga Park, California, United States (Recruiting)
• Ark Clinical Research — Long Beach, California, United States (Recruiting)
• Catalina Research Institute, LLC — Montclair, California, United States (Recruiting)
• Paradigm Clinical Research Centers, LLC — San Diego, California, United States (Recruiting)
• Southwest General Healthcare Center — Fort Myers, Florida, United States (Recruiting)
• Panax Clinical Research — Miami Lakes, Florida, United States (Recruiting)
• Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States (Recruiting)
• David Kavtaradze MD, Inc — Cordele, Georgia, United States (Recruiting)
• Excel Clinical Research — Las Vegas, Nevada, United States (Recruiting)
• Diabetes and Endocrinology Associates of Stark County — Canton, Ohio, United States (Recruiting)
• Elligo Health Research, Inc. — Austin, Texas, United States (Recruiting)
• Zenos Clinical Research — Dallas, Texas, United States (Recruiting)
• Synergy Groups Medical — Houston, Texas, United States (Recruiting)
• Epic Clinical Research — Lewisville, Texas, United States (Recruiting)
• Manassas Clinical Research Center — Manassas, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Biomea Fusion Inc.

Conditions Type 2 Diabetes