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HomeTrials › NCT07502508

Type 2 diabetes · Phase 2 · Recruiting now

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy

NCT07502508 · Sponsor: Biomea Fusion Inc.

What this trial means for you

This study is recruiting now at 16 US sites. It's studying icovamenib 100 mg, Placebo for type 2 diabetes.

Who can joinAll sexes, 18 Years – 70 Years
Healthy volunteersNo — diagnosis required
What you'd takeicovamenib 100 mg, Placebo
Study length~14 months overall
Planned participants60
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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 Ozempic-based therapy.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Alabama

  • Central Research Associates, LLC dba Flourish Research — Birmingham · Recruiting now

California

  • Hope Clinical Research — Canoga Park · Recruiting now
  • Ark Clinical Research — Long Beach · Recruiting now
  • Catalina Research Institute, LLC — Montclair · Recruiting now
  • Paradigm Clinical Research Centers, LLC — San Diego · Recruiting now

Florida

  • Southwest General Healthcare Center — Fort Myers · Recruiting now
  • Panax Clinical Research — Miami Lakes · Recruiting now

Georgia

  • David Kavtaradze MD, Inc — Cordele · Recruiting now

Nevada

  • Excel Clinical Research — Las Vegas · Recruiting now

Ohio

  • Diabetes and Endocrinology Associates of Stark County — Canton · Recruiting now

Texas

  • Elligo Health Research, Inc. — Austin · Recruiting now
  • Zenos Clinical Research — Dallas · Recruiting now
  • Synergy Group Medical — Houston · Recruiting now
  • Epic Clinical Research — Lewisville · Recruiting now
  • Diabetes & Glandular Disease Clinic, P.A. — San Antonio · Recruiting now

Virginia

  • Burke Internal Medicine and Research — Burke · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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