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Active not recruitingPhase 1

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

Biomea Fusion Inc.

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

80

estimated

Study population

Obesity / overweight

Key I/E criteria

BMI 25-40HbA1c ≤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

NCT IDNCT07223216
Org study IDGLP-131

Timeline

Milestones

Study start2025-10-23actual
Study first posted2025-10-31actual
Last update posted2026-04-09actual
Primary completion2026-05estimated (month precision)
Study completion2026-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

Safety / tolerability / PK
10
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Assess 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 endpoints
Primary/protocol endpoint

Assess safety and tolerability of BMF-650

Time frame:6 weeks (Part 1) and 11 weeks (Part 2)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Assess safety and tolerability of BMF-650

Time frame:6 weeks (Part 1) and 11 weeks (Part 2)

descriptive

Primary/protocol endpoint

Assess safety and tolerability of BMF-650

Time frame:6 weeks (Part 1) and 11 weeks (Part 2)

descriptive

Primary/protocol endpoint

Assess safety and tolerability of BMF-650

Time frame:6 weeks (Part 1) and 11 weeks (Part 2)

descriptive

Primary/protocol endpoint

Assess safety and tolerability of BMF-650

Time frame:6 weeks (Part 1) and 11 weeks (Part 2)

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.