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Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-650 in Otherwise Healthy Overweight or Obese Participants.
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
80
estimated
Study population
Obesity / overweight
Key I/E criteria
•BMI 25-40•HbA1c ≤6.5%•Healthy volunteers
Primary endpoints
•Treatment-emergent AEs (any)•Assess safety and tolerability of BMF-650
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
4. For Part 1 (SAD cohorts), BMI of 25.0 to 40.0 kg/m2 as measured at screening, with no chronic health conditions.
5. For Part 2 (MAD cohorts), BMI of 30.0 to 45.0 kg/m2, as measured at screening with no chronic health conditions.
6. Have a stable body weight (less than or equal to 5% body weight gain or loss) for 3 months prior to screening.
7. HbA1c ≤ 6.5%
Exclusion criteria
Medical/Surgical History and Mental Health
1. Known self or family history (first-degree relative) of medullary thyroid cancer and/or multiple endocrine neoplasia Type 2 (MEN2).
2. History of stomach or intestinal surgery or resection and/or gastroparesis (except that appendectomy and/or hernia repair will be allowed).
3. Significant history of or currently have major depressive disorder or psychiatric disorder or suicidal ideation within the last 2 years.
4. Severe uncontrolled treated or untreated hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP >90 mmHg).
5. Mean QTcF interval greater than 450 msec on triplicate ECGs.
Diagnostic Assessments
6. Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator
7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
8. eGFR of <60 mL/min/1.73 m2
9. AST, ALT or total bilirubin > ULN
10. Lipase and/or amylase > ULN
11. Calcitonin ≥20 ng/L
Prior Study Participation
12. Participants who have received any IMP in a clinical research study within 5 half -lives or within 30 days prior to first dose
Prior and Concomitant Medication
13. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than HRT/hormonal contraception) in the 14 days before first IMP administration
14. Use of prescription or over-the-counter medications known to significantly prolong the QT or QTc interval is excluded.
15. Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management
16. Participants who have previously used GLP-1 receptor agonist, or GIP/GLP-1 dual receptor agonists, or any investigational medicine containing a GLP-1 and/or GIP receptor agonist in the 6 months prior to first IMP administration
Endpoints (11)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointAssess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only)
Time frame:6 weeks
Body weight, % change
percent change from baseline, improvement
Safety / tolerability / PK
10 endpointsAssess safety and tolerability of BMF-650
Time frame:6 weeks (Part 1) and 11 weeks (Part 2)
Treatment-emergent AEs (any)
event count, event
Assess safety and tolerability of BMF-650
Time frame:6 weeks (Part 1) and 11 weeks (Part 2)
descriptive
Assess safety and tolerability of BMF-650
Time frame:6 weeks (Part 1) and 11 weeks (Part 2)
descriptive
Assess safety and tolerability of BMF-650
Time frame:6 weeks (Part 1) and 11 weeks (Part 2)
descriptive
Assess safety and tolerability of BMF-650
Time frame:6 weeks (Part 1) and 11 weeks (Part 2)
Treatment-emergent AEs (any)
descriptive
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame:2 weeks (Part 1) and 6 weeks (Part 2)
Tmax
concentration, descriptive
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame:2 weeks (Part 1) and 6 weeks (Part 2)
Cmax
concentration, descriptive
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame:2 weeks (Part 1) and 6 weeks (Part 2)
AUC₀–∞
concentration, descriptive
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame:2 weeks (Part 1) and 6 weeks (Part 2)
AUC₀–∞
concentration, descriptive
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame:2 weeks (Part 1) and 6 weeks (Part 2)
Half-life
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.