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.
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
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 group | Role | What they receive |
|---|---|---|
| Part 1 SAD Cohort 1 (Regimen A) | Experimental | BMF-650 Tablets 10 mg or matching placebo in fasted state Receives: 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) Receives: Drug: BMF-650 |
| Part 1 SAD Cohort 3 (Regimen D) | Experimental | BMF-650 Tablets 50 mg or matching placebo in fasted state Receives: Drug: BMF-650 |
| Part 1 SAD Cohort 4 (Regimen E and F) | 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) Receives: Drug: BMF-650 |
| Part 1 SAD Cohort 5 (Regimen G) | Experimental | BMF-650 Tablets 200 mg or matching placebo in fasted state Receives: 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. Receives: 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. Receives: 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. Receives: Drug: BMF-650 |
| Part 2 MAD Cohort 4 (Regimen K) | 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. Receives: Drug: BMF-650 |
| Part 2 MAD Cohort 5 (Regimen L) | Experimental | BMF-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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted31 Oct 2025
- Study start23 Oct 2025
- Primary completion12 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Biomea Fusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biomea Fusion Inc., Study director, Biomea Fusion Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07223216
- Acronym / sponsor ID
- GLP-131
- Conditions
- Obesity
- Keywords
- Obesity, Obese, Overweight, Weight-loss, GLP-1, GLP-1 agonist, GLP-1 receptor agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Biomea Fusion Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD Cohort 1 (Regimen A) | Experimental | Drug: BMF-650BMF-650 Tablets 10 mg or matching placebo in fasted state |
| Part 1 SAD Cohort 2 (Regimen B and C) | Experimental | Drug: BMF-650Regimen 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) |
| Part 1 SAD Cohort 3 (Regimen D) | Experimental | Drug: BMF-650BMF-650 Tablets 50 mg or matching placebo in fasted state |
| Part 1 SAD Cohort 4 (Regimen E and F) | Experimental | Drug: BMF-650Regimen 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) |
| Part 1 SAD Cohort 5 (Regimen G) | Experimental | Drug: BMF-650BMF-650 Tablets 200 mg or matching placebo in fasted state |
| Part 2 MAD Cohort 1 (Regimen H) | Experimental | Drug: BMF-650BMF-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. |
| Part 2 MAD Cohort 2 (Regimen I) | Experimental | Drug: BMF-650BMF-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. |
| Part 2 MAD Cohort 3 (Regimen J) | Experimental | Drug: BMF-650BMF-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. |
| Part 2 MAD Cohort 4 (Regimen K) | Experimental | Drug: BMF-650BMF-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. |
| Part 2 MAD Cohort 5 (Regimen L) | Experimental | Drug: BMF-650BMF-650 Tablets or matching placebo in fasted state 200 mg QD for 7 days; 400 mg QD for 21 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMF-650Interventional Product | Drug | 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), Part 1 SAD Cohort 5 (Regimen G), 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), Part 2 MAD Cohort 5 (Regimen L) |
Primary outcome
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)
Incidence of adverse events (AEs)
Assess safety and tolerability of BMF-650
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Vital signs like blood pressure
Assess safety and tolerability of BMF-650
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
ECG measures like QTcF interval
Assess safety and tolerability of BMF-650
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Physical examinations like general appearance
Assess safety and tolerability of BMF-650
Time frame: 2 weeks (Part 1), 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Safety labs like clinical chemistry
6 secondary outcomes
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4 ) and 4 weeks (Part 2 MAD Cohort 5)
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohort 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Evaluate PK and food effect of BMF-650 in fed and fasted states
Time frame: 2 weeks (Part 1) 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Assess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only)
Time frame: 4 and 6 weeks (Part 2 MAD Cohorts 1-4) and 4 weeks (Part 2 MAD Cohort 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biomea Fusion Inc. study director
Biomea Fusion Inc.
1 site in 1 country: see every site and its status.
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.