Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Type 2 Diabetes Mellitus, Healthy Volunteers
Brief summary
A Phase 1/ 2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adult Subjects and in Adult Subjects with Type 2 Diabetes Mellitus.
Detailed description
This is a Phase 1/ 2 study that will examine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple dose levels of BMF-219, an orally bioavailable selective covalent inhibitor of menin, in healthy subjects and in subjects with T2D. This study will assess the effect of BMF-219 as single ascending dose (SAD) and multiple ascending dose (MAD), Expansion Cohort will explore 100mg and 200mg dose levels.
Interventions
DRUGBMF-219
Investigational Product
Sponsors
Biomea Fusion Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The subject and the investigator involved in the treatment or clinical evaluation of the subjects will be unaware of the group assignments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Subject Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. BMI ≥18 and ≤35 kg/m2. 3. Subjects are healthy on the basis of their medical history, physical examination, ECG, and routine laboratory data. 4. All subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Subjects with T2D: (MAD Cohorts) Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. Diagnosed with T2D within the last 15 years. 3. Treated with lifestyle management with or without at the most 3 anti-diabetic medications with a stable dose for at least 2 months prior to screening. If on metformin, the stable dose should be at least 500mg/day. 4. HbA1c ≥7.0% and ≤10.5%. 5. BMI ≥25 and ≤40 kg/m2. 6. Females are to be not pregnant, non-lactating. 7. All Subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Subjects with T2D: (Expansion Cohort) Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. Diagnosed with T2D within the last 7 years. 3. Treated with lifestyle management with or without at the most 3 anti-diabetic medications with a stable dose for at least 2 months prior to screening. If on metformin, the stable dose should be at least 500mg/day. 4. HbA1c ≥7.0% and ≤10.5%. 5. BMI ≥25 and ≤40 kg/m2. 6. Females are to be not pregnant, non-lactating. 7. All Subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
Exclusion criteria
Healthy Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments | 52 weeks | Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations. |
| Pharmacokinetics Assessments | 12 weeks | Assessed by effect of fed conditions on serial and sparse pharmacokinetic data. |
| Change in HbA1c | 26 weeks | Assess the change in HbA1c from baseline to week 26. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect on HbA1c | 26 Weeks | Proportion of subjects achieving an HbA1c \< 7% at Week 26. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory: To determine the impact of multiple ascending doses of BMF-219 on beta-cell function in subjects with T2D. | Week 26 | Descriptive summaries of homeostatic model assessment beta-cell function %beta and insulin resistance (HOMA-B and HOMA- IR). |
| Exploratory: To determine the effects of BMF-219 on glycemic parameters in subjects with T2D. | Week 26 | Assess changes in plasma glucose, c-peptide, and insulin at different timepoints by both fasted and in response to OGTT. |
Countries
Canada, United States
Outcome results
None listed