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

NCT07223216 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GLP-131
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Obese; Overweight; Weight-loss; GLP-1; GLP-1 agonist; GLP-1 receptor agonist

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Evaluate PK and food effect of BMF-650 in fed and fasted states

  2 weeks (Part 1) and 6 weeks (Part 2)

• Evaluate PK and food effect of BMF-650 in fed and fasted states

  2 weeks (Part 1) and 6 weeks (Part 2)

• Evaluate PK and food effect of BMF-650 in fed and fasted states

  2 weeks (Part 1) and 6 weeks (Part 2)

• Evaluate PK and food effect of BMF-650 in fed and fasted states

  2 weeks (Part 1) and 6 weeks (Part 2)

• Evaluate PK and food effect of BMF-650 in fed and fasted states

  2 weeks (Part 1) and 6 weeks (Part 2)

Study Arms (9)

Part 1 SAD Cohort 1 (Regimen A)

EXPERIMENTAL

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

Drug: BMF-650

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)

Drug: BMF-650

Part 1 SAD Cohort 3 (Regimen D)

EXPERIMENTAL

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

Drug: BMF-650

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)

Drug: BMF-650

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

EXPERIMENTAL

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

Drug: BMF-650

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.

Drug: BMF-650

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.

Drug: BMF-650

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.

Drug: BMF-650

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.

Drug: BMF-650

Interventions

BMF-650 DRUG

Interventional Product

Part 1 SAD Cohort 1 (Regimen A); Part 1 SAD Cohort 2 (Regimen B and C); Part 1 SAD Cohort 3 (Regimen D); Part 1 SAD Cohort 4 (Regimen E and F) (Optional); Part 1 SAD Cohort 5 (Regimen G) (Optional); Part 2 MAD Cohort 1 (Regimen H); Part 2 MAD Cohort 2 (Regimen I); Part 2 MAD Cohort 3 (Regimen J); Part 2 MAD Cohort 4 (Regimen K) (Optional)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
• Must be willing and able to comply with all study requirements
• Healthy males or non-pregnant, non-lactating healthy females with obesity or overweight.
• For Part 1 (SAD cohorts), BMI of 25.0 to 40.0 kg/m2 as measured at screening, with no chronic health conditions.
• For Part 2 (MAD cohorts), BMI of 30.0 to 45.0 kg/m2, as measured at screening with no chronic health conditions.
• Have a stable body weight (less than or equal to 5% body weight gain or loss) for 3 months prior to screening.
• HbA1c ≤ 6.5%

You may not qualify if:

• Medical/Surgical History and Mental Health
• Known self or family history (first-degree relative) of medullary thyroid cancer and/or multiple endocrine neoplasia Type 2 (MEN2).
• History of stomach or intestinal surgery or resection and/or gastroparesis (except that appendectomy and/or hernia repair will be allowed).
• Significant history of or currently have major depressive disorder or psychiatric disorder or suicidal ideation within the last 2 years.
• Severe uncontrolled treated or untreated hypertension (systolic blood pressure \[BP\] \>150 mmHg or diastolic BP \>90 mmHg).
• Mean QTcF interval greater than 450 msec on triplicate ECGs.
• Diagnostic Assessments
• Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
• eGFR of \<60 mL/min/1.73 m2
• AST, ALT or total bilirubin \> ULN
• Lipase and/or amylase \> ULN
• Calcitonin ≥20 ng/L
• Prior Study Participation
• Participants who have received any IMP in a clinical research study within 5 half -lives or within 30 days prior to first dose

Sponsors & Collaborators

• Biomea Fusion Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Biomea Fusion Inc.

  Biomea Fusion Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: October 23, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)