Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05731544 | Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D) | PHASE1 | COMPLETED | 443 | — | — | Aug 17, 2022 | Jul 8, 2025 | Nov 10, 2025 | 39 | United States, Canada |
Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations.
Assessed by effect of fed conditions on serial and sparse pharmacokinetic data.
Assess the change in HbA1c from baseline to week 26.
| Arm | Type | Description |
|---|---|---|
| Phase 1 SAD Cohorts | EXPERIMENTAL | 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. |
| Phase 1 single dose food effect sub-study | EXPERIMENTAL | 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. |
| Phase 1 single dose tablet PK sub-study | EXPERIMENTAL | 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). |
| Phase 2 MAD Cohorts | EXPERIMENTAL | 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. |
| Phase 2 Expansion Cohort | EXPERIMENTAL | Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo. |
| Name | Type | Description |
|---|---|---|
| BMF-219 | DRUG | Investigational Product |
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 w...