Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMF-650 · 1 trial · 1 indication
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....
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BMF-650 is an investigational small molecule being developed for the treatment of obesity. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in otherwise healthy overweight or obese adult participants.
BMF-650 targets the GLP-1 receptor. GLP-1 receptor agonists are known to help regulate appetite and blood sugar, which is relevant for obesity treatment. As a small molecule targeting this receptor, BMF-650 is being investigated for its potential effects in overweight or obese individuals.
BMF-650 is being developed by Biomea Fusion, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol BMEA. The company is conducting clinical research on this small molecule for obesity.
BMF-650 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and the drug is being studied in the United States.
BMF-650 is being studied in a Phase 1 clinical trial with the identifier NCT07223216, titled "Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants." This randomized, double-blind, controlled trial has an enrollment of 80 participants and is being conducted in the United States.