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Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants

NCT ID: NCT07223216

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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This is a single center, double-blind, randomized, placebo-controlled, first-in-human (FIH) study of BMF-650, an oral non-peptide GLP-1 receptor agonist administered to otherwise healthy overweight or obese participants. Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.

Conditions

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Obesity

Keywords

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Obesity Obsess Overweight Weight-loss GLP-1 GLP-1 agonist GLP-1 receptor agonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single center, double-blind, randomized, placebo-controlled, first-in-human (FIH) study of BMF-650, an oral non-peptide GLP-1 receptor agonist administered to otherwise healthy overweight or obese participants. Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
This is a double-blind study. Treatment assignment will not be known to the participants, the sponsor or the staff who are involved in the clinical evaluation of the participants and the analysis of data as indicated in the blinding plan. If appearance matching of the placebo is not possible then use of masking and/or unblinded dosing teams will be used to preserve the study blind.

Study Groups

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Part 1 SAD Cohort 1 (Regimen A)

BMF-650 Tablets 10 mg or matching placebo in fasted state

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 1 SAD Cohort 2 (Regimen B and C)

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)

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 1 SAD Cohort 3 (Regimen D)

BMF-650 Tablets 50 mg or matching placebo in fasted state

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 1 SAD Cohort 4 (Regimen E and F) (Optional)

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)

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 1 SAD Cohort 5 (Regimen G) (Optional)

BMF-650 Tablets 200 mg or matching placebo in fasted state

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 2 MAD Cohort 1 (Regimen H)

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.

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 2 MAD Cohort 2 (Regimen I)

BMF-650 Tablets or matching placebo in fasted state

25 mg QD for 7 days; 50 mg QD for 7 days; 100 mg QD for 7 days; 200 mg QD for 21 days.

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 2 MAD Cohort 3 (Regimen J)

BMF-650 Tablets or matching placebo in fasted state

25 mg QD for 7 days; 75 mg QD for 7 days; 150 mg QD for 7 days; 300 mg QD for 21 days.

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Part 2 MAD Cohort 4 (Regimen K) (Optional)

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 7 days; 400 mg QD for 21 days.

Group Type EXPERIMENTAL

BMF-650

Intervention Type DRUG

Interventional Product

Interventions

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BMF-650

Interventional Product

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biomea Fusion Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Biomea Fusion Inc.

Role: STUDY_DIRECTOR

Biomea Fusion Inc.

Locations

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Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Biomea Fusion Inc.

Role: CONTACT

Phone: 1-844-245-0490

Email: [email protected]

Other Identifiers

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GLP-131

Identifier Type: -

Identifier Source: org_study_id