BMF-219 for Type 2 Diabetes
Trial Summary
What is the purpose of this trial?
This trial tests a new pill called BMF-219 that targets a protein named menin. It includes healthy adults and those with Type 2 Diabetes to see if it helps control blood sugar levels.
Will I have to stop taking my current medications?
If you are taking certain anti-diabetes medications like sulfonylureas, insulin, or specific DPP-4 inhibitors (linagliptin and saxagliptin), you will need to stop them at least 2 months before joining the trial. Other medications may be allowed if they have been stable for at least 2 months prior to screening.
What makes the drug BMF-219 unique for treating type 2 diabetes?
BMF-219, also known as Icovamenib, is a covalent menin inhibitor, which is a novel approach for treating type 2 diabetes. Unlike traditional treatments that focus on insulin resistance or secretion, this drug targets a different pathway, potentially offering a new mechanism to manage the condition.12345
Research Team
Stephen Morris, MD
Principal Investigator
Biomea Fusion Inc.
Eligibility Criteria
Adults aged 18-65 with Type 2 Diabetes Mellitus (T2DM) and a BMI of 25-40 kg/m^2, or healthy adults within the same age range but with a BMI of 18-35 kg/m^2. Participants must not be pregnant, should use contraception if applicable, and have stable health as determined by medical history and tests. Treated T2DM subjects may be on up to three anti-diabetic medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Single Ascending Dose (SAD)
Participants receive single ascending doses of BMF-219 or placebo to evaluate safety, tolerability, PK, and PD
Phase 2 Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses of BMF-219 or placebo to evaluate safety, tolerability, PK, and PD
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BMF-219
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biomea Fusion Inc.
Lead Sponsor