🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07502508
Recruiting Phase 2

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 · tracked via the Priya Life Science USA tracker
Sponsor
Biomea Fusion Inc.
Phase
Phase 2
Started
2026-04-30
Last updated
2026-06-15

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

icovamenib 100 mg →Placebo

icovamenib 100 mg: icovamenib 100 mg

Placebo: Matching placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Key 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 * If participants are taking metformin, they must be on a minimum stable dose of ≥500 mg/day * Participants must be on a minimum stable dose of Ozempic ≥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, 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 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

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Central Research Associates, LLC dba Flourish Research Birmingham Alabama Recruiting
Hope Clinical Research Canoga Park California Recruiting
Ark Clinical Research Long Beach California Recruiting
Catalina Research Institute, LLC Montclair California Recruiting
Paradigm Clinical Research Centers, LLC San Diego California Recruiting
Southwest General Healthcare Center Fort Myers Florida Recruiting
Panax Clinical Research Miami Lakes Florida Recruiting
Flourish Research Orlando Winter Park Florida Recruiting
David Kavtaradze MD, Inc Cordele Georgia Recruiting
Excel Clinical Research Las Vegas Nevada Recruiting
Diabetes and Endocrinology Associates of Stark County Canton Ohio Recruiting
Elligo Health Research, Inc. Austin Texas Recruiting
Zenos Clinical Research Dallas Texas Recruiting
Synergy Group Medical Houston Texas Recruiting
Epic Clinical Research Lewisville Texas Recruiting
Diabetes & Glandular Disease Clinic, P.A. San Antonio Texas Recruiting
Burke Internal Medicine and Research Burke Virginia Recruiting

More Biomea Fusion Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07502508 on ClinicalTrials.gov ↗ ← All trials in the USA