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ObesityPhase 1NCT07223216

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

A Phase 1 study testing BMF-650 in people with Obesity, run by Biomea Fusion Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
BMF-650
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
23 Oct 2025to 26 Aug 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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% at screening

Who cannot join

  • 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.
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  • 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
  • Prior and Concomitant Medication
  • 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
  • Use of prescription or over-the-counter medications known to significantly prolong the QT or QTc interval is excluded.
  • Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medpace Clinical Pharmacology

    Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
BMF-650
Keywords
Obesity, Obese, Overweight, Weight-loss, GLP-1, GLP-1 agonist, GLP-1 receptor agonist
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMF-650Drug

    Interventional Product

Study groups in NCT07223216
Study groupRoleWhat they receive
Part 1 SAD Cohort 1 (Regimen A)ExperimentalBMF-650 Tablets 10 mg or matching placebo in fasted state
Receives: Drug: BMF-650
Part 1 SAD Cohort 2 (Regimen B and C)ExperimentalRegimen 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)
Receives: Drug: BMF-650
Part 1 SAD Cohort 3 (Regimen D)ExperimentalBMF-650 Tablets 50 mg or matching placebo in fasted state
Receives: Drug: BMF-650
Part 1 SAD Cohort 4 (Regimen E and F)ExperimentalRegimen 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)
Receives: Drug: BMF-650
Part 1 SAD Cohort 5 (Regimen G)ExperimentalBMF-650 Tablets 200 mg or matching placebo in fasted state
Receives: Drug: BMF-650
Part 2 MAD Cohort 1 (Regimen H)ExperimentalBMF-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.
Receives: Drug: BMF-650
Part 2 MAD Cohort 2 (Regimen I)ExperimentalBMF-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.
Receives: Drug: BMF-650
Part 2 MAD Cohort 3 (Regimen J)ExperimentalBMF-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.
Receives: Drug: BMF-650
Part 2 MAD Cohort 4 (Regimen K)ExperimentalBMF-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.
Receives: Drug: BMF-650
Part 2 MAD Cohort 5 (Regimen L)ExperimentalBMF-650 Tablets or matching placebo in fasted state 200 mg QD for 7 days; 400 mg QD for 21 days
Receives: Drug: BMF-650

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess safety and tolerability of BMF-650

    Incidence of adverse events (AEs)

    Measured: 6 weeks (Part 1) 4 and 11 weeks (Part 2 MAD Cohorts 1-4) and 6 weeks (Part 2 MAD Cohort 5)

  2. Assess safety and tolerability of BMF-650

    Vital signs like blood pressure

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

  3. Assess safety and tolerability of BMF-650

    ECG measures like QTcF interval

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

  4. Assess safety and tolerability of BMF-650

    Physical examinations like general appearance

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

  5. Assess safety and tolerability of BMF-650

    Safety labs like clinical chemistry

    Measured: 2 weeks (Part 1), 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

Secondary outcomes (6)
  1. Evaluate PK and food effect of BMF-650 in fed and fasted states

    Tmax

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

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

    Cmax

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4 ) and 4 weeks (Part 2 MAD Cohort 5)

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

    AUC(0-last)

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohort 1-4) and 4 weeks (Part 2 MAD Cohort 5)

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

    AUC(0-inf)

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

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

    T1/2

    Measured: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

  6. Assess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only)

    Percent change in body weight compared to baseline

    Measured: 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2025
  2. Study start23 Oct 2025
  3. Primary completion12 Aug 2026
  4. Study completion26 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model 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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223216
Sponsor's protocol ID
GLP-131
Status last verified
Oct 2026
First submitted
29 Oct 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMF-650 in people with Obesity, run by Biomea Fusion Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess safety and tolerability of BMF-650 (time frame: 6 weeks (Part 1) 4 and 11 weeks (Part 2 MAD Cohorts 1-4) and 6 weeks (Part 2 MAD Cohort 5)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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