BMF-219 for Type 2 Diabetes

Recruiting at49 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Biomea Fusion Inc.

No Placebo Group

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.

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

HbA1c ≥7.0% and ≤10% at screening.

Subjects with T2DM: Males with partners who are female with reproductive potential must agree to use effective contraceptive methods

BMI ≥18 and ≤40 kg/m2.

Exclusion Criteria

Healthy Subjects: History or evidence of HIV, HCV, HBV, or active COVID-19 infection

Healthy Subjects: Significant blood loss, blood donation, or blood transfusion within 2 months prior to dosing

Healthy Subjects: Seville oranges, grapefruit, grapefruit hybrids or grapefruit juice, pomelos, exotic citrus fruits or fruit juices ingestion or treatment with any CYP3A4 inhibitor, inducer, or substrate within a week prior to dosing

Treatment Details

Interventions

• BMF-219 (Covalent Menin Inhibitor)

Trial Overview The trial is testing BMF-219, an oral covalent menin inhibitor. It's a randomized, double-blind study comparing the effects of BMF-219 against a placebo in both healthy adults and those with T2DM to assess safety, tolerability, how the body processes it (pharmacokinetics), and its effectiveness (pharmacodynamics).

Participant Groups

Group I: Phase 2 MAD Cohorts Experimental Treatment 1 Intervention

Phase 2 MAD Cohorts with healthy adults (MAD 1, randomized 3:1) or adults with T2D (MAD 2-4 \& 6-8, randomized 5:1) receiving BMF-219 or placebo. MAD 5 is BMF-219 only.

Group II: Phase 2 Expansion Cohort Experimental Treatment 1 Intervention

Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo.

Group III: Phase 1 single dose tablet PK sub-study Experimental Treatment 1 Intervention

Phase 1 single dose x3 PK tablet open-label sub-study with healthy adults randomized 1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high-fat meal).

Group IV: Phase 1 single dose food effect sub-study Experimental Treatment 1 Intervention

Phase 1 single dose food effect sub-study with healthy adults randomized 1:1:1:1:1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high fat meal.

Group V: Phase 1 SAD Cohorts Experimental Treatment 1 Intervention

Phase 1 SAD Cohorts with healthy adults randomized 3:1 receiving BMF-219 or placebo. A pair of sentinel subjects (randomly assigned 1 active drug and 1 placebo) will be dosed 48 hours prior to dosing of the remainder of subjects in each cohort.

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials

5

Recruited

780+