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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: BMF-650

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 SAD Cohort 1 (Regimen A); BMF-650 Tablets 10 mg or matching placebo in fasted state	Drug: BMF-650; Interventional Product
Experimental: 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)	Drug: BMF-650; Interventional Product
Experimental: Part 1 SAD Cohort 3 (Regimen D); BMF-650 Tablets 50 mg or matching placebo in fasted state	Drug: BMF-650; Interventional Product
Experimental: 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)	Drug: BMF-650; Interventional Product
Experimental: Part 1 SAD Cohort 5 (Regimen G) (Optional); BMF-650 Tablets 200 mg or matching placebo in fasted state	Drug: BMF-650; Interventional Product
Experimental: 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.	Drug: BMF-650; Interventional Product
Experimental: Part 2 MAD Cohort 2 (Regimen I); 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.	Drug: BMF-650; Interventional Product
Experimental: Part 2 MAD Cohort 3 (Regimen J); 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.	Drug: BMF-650; Interventional Product
Experimental: Part 2 MAD Cohort 4 (Regimen K) (Optional); 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.	Drug: BMF-650; Interventional Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess safety and tolerability of BMF-650	Incidence of adverse events (AEs)	6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650	Vital signs like blood pressure	6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650	ECG measures like QTcF interval	6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650	Physical examinations like general appearance	6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650	Safety labs like clinical chemistry	6 weeks (Part 1) and 11 weeks (Part 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate PK and food effect of BMF-650 in fed and fasted states	Tmax	2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states	Cmax	2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states	AUC(0-last)	2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states	AUC(0-inf)	2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states	T1/2	2 weeks (Part 1) and 6 weeks (Part 2)
Assess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only)	Percent change in body weight compared to baseline	6 weeks

Collaborators and Investigators

• Sponsor: Biomea Fusion Inc.
• Investigators: Study Director: Biomea Fusion Inc., Biomea Fusion Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; GLP-1; GLP-1 agonist; Overweight; Obese; GLP-1 receptor agonist; Weight-loss
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss
• Other Study ID Numbers: GLP-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No