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414 Participants Needed

BMF-219 for Type 2 Diabetes

Recruiting at 49 trial locations

Overseen ByRima Sakhapara

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Biomea Fusion Inc.

Must be taking: Anti-diabetics

Must not be taking: Sulfonylureas, Insulin, DPP-4 inhibitors

Disqualifiers: Hypertension, MEN1, HIV, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.¹ ² ³ ⁴ ⁵

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.

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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

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Single Ascending Dose (SAD)

Participants receive single ascending doses of BMF-219 or placebo to evaluate safety, tolerability, PK, and PD

12 weeks

Multiple visits for dosing and assessments

Phase 2 Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of BMF-219 or placebo to evaluate safety, tolerability, PK, and PD

26 weeks

Regular visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Treatment Details

Interventions

BMF-219

Trial OverviewThe 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

5Treatment groups

Experimental Treatment

Group I: Phase 2 MAD CohortsExperimental Treatment1 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 CohortExperimental Treatment1 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-studyExperimental Treatment1 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-studyExperimental Treatment1 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 CohortsExperimental Treatment1 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.