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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07223216 | Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants | PHASE1 | ACTIVE NOT_RECRUITING | 80 | — | — | Oct 23, 2025 | Jun 1, 2026 | Apr 9, 2026 | 1 | United States |
Incidence of adverse events (AEs)
| Arm | Type | Description |
|---|---|---|
| Part 1 SAD Cohort 1 (Regimen A) | EXPERIMENTAL | BMF-650 Tablets 10 mg or matching placebo in fasted state |
| Part 1 SAD Cohort 2 (Regimen B and C) | EXPERIMENTAL | Regimen B: BMF-650 Tablets 25 mg or matching placebo in fasted state Regimen C: BMF-650 Tablets 25 mg or matching placebo in fed state (high-fat breakfast 30 minutes before BMF-650 or placebo is administered) |
| Part 1 SAD Cohort 3 (Regimen D) | EXPERIMENTAL | BMF-650 Tablets 50 mg or matching placebo in fasted state |
| Part 1 SAD Cohort 4 (Regimen E and F) (Optional) | EXPERIMENTAL | Regimen E: BMF-650 Tablets 100 mg or matching placebo in fasted state Regimen F: BMF-650 Tablets 100 mg or matching placebo in fed state (high-fat breakfast 30 minutes before BMF-650 or placebo is administered) |
| Part 1 SAD Cohort 5 (Regimen G) (Optional) | EXPERIMENTAL | BMF-650 Tablets 200 mg or matching placebo in fasted state |
| Part 2 MAD Cohort 1 (Regimen H) | EXPERIMENTAL | BMF-650 Tablets or matching placebo in fasted state 10 mg QD for 7 days; 25 mg QD for 7 days; 50 mg QD for 7 days; 100 mg QD for 21 days. |
| Part 2 MAD Cohort 2 (Regimen I) | EXPERIMENTAL | BMF-650 Tablets or matching placebo in fasted state 50 mg QD for 7 days; 100 mg QD for 7 days; 200 mg QD for 28 days. |
| Part 2 MAD Cohort 3 (Regimen J) | EXPERIMENTAL | BMF-650 Tablets or matching placebo in fasted state 75 mg QD for 7 days; 150 mg QD for 7 days; 300 mg QD for 28 days. |
| Part 2 MAD Cohort 4 (Regimen K) (Optional) | EXPERIMENTAL | BMF-650 Tablets or matching placebo in fasted state 75 mg QD for 7 days; 200 mg QD for 7 days; 400 mg QD for 28 days. |
| Name | Type | Description |
|---|---|---|
| BMF-650 | DRUG | Interventional Product |
Inclusion Criteria: 1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. 2. Must be willing and able to comply with all study requirements 3. Healthy males or non-pregnant, non-lactating healthy females with obesity or overweight....