Add-on icovamenib for people with type 2 diabetes not reaching blood sugar targets on Ozempic

Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy

This trial will test whether adding icovamenib to Ozempic helps adults with type 2 diabetes who still have HbA1c above target after at least three months on Ozempic.

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: NCT07502508 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 as an add-on to an Ozempic-based regimen in adults with type 2 diabetes. Eligible participants must have been on stable semaglutide (Ozempic) for at least three months, have HbA1c 7.5–9.5%, and BMI 25–40 kg/m2, with stable background use of metformin and/or an SGLT2 inhibitor allowed. The primary endpoint is change in HbA1c versus placebo, and safety and tolerability will be monitored throughout the 52 weeks. Enrollment occurs at three U.S. outpatient clinical research sites with scheduled clinic visits and laboratory monitoring.

Who should consider this trial

Good fit: Adults 18–70 years with type 2 diabetes who have been on a stable Ozempic regimen (≥0.5 mg/week) for at least three months, have HbA1c 7.5%–9.5%, BMI 25–40 kg/m2, and stable background therapy (metformin and/or SGLT2 inhibitor if used) are the intended participants.

Not a fit: People with type 1 or secondary diabetes, those not using Ozempic, pregnant or breastfeeding individuals, or those outside the specified HbA1c or BMI ranges are unlikely to benefit from this specific add-on treatment.

Why it matters

Potential benefit: If successful, adding icovamenib to Ozempic could lower HbA1c in people not reaching glycemic targets, improving glucose control and potentially reducing diabetes-related risks.

How similar studies have performed: Combining additional glucose-lowering agents with GLP-1 receptor agonists has produced further glycemic benefits in prior studies, but icovamenib is a novel agent and this randomized phase 2 trial is an early clinical test of its effect.

Eligibility criteria

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

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)
• 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 Group Medical — Houston, Texas, United States (Recruiting)
• Epic Clinical Research — Lewisville, Texas, United States (Recruiting)
• Diabetes & Glandular Disease Clinic, P.A. — San Antonio, Texas, United States (Recruiting)
• Burke Internal Medicine and Research — Burke, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Biomea Fusion Inc.

Conditions Type 2 Diabetes