BMF-650 for Obesity

Overseen By Biomea Fusion Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biomea Fusion Inc.

Must not be taking: QT prolonging drugs, Weight loss drugs

Disqualifiers: Thyroid cancer, Depression, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMF-650, designed to help individuals who are overweight or obese. Researchers aim to ensure the treatment's safety, understand its mechanism in the body, and assess its tolerability. Participants will receive different doses of BMF-650 or a placebo (a pill with no active medicine). The trial suits those who are overweight or obese, have maintained a stable body weight for the past three months, and have no chronic health issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescribed or over-the-counter drugs or herbal remedies (except hormone replacement therapy or hormonal contraception) 14 days before starting the trial medication.

Is there any evidence suggesting that BMF-650 is likely to be safe for humans?

Research has shown that BMF-650 has been safe in early testing. In past studies, participants handled it well, with no major safety issues or severe side effects. This suggests BMF-650 might be a safe choice for those considering joining the trial. However, as this trial is still in the early stages, more information is needed about its long-term safety in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or procedures such as bariatric surgery, BMF-650 offers a novel approach. Researchers are excited about BMF-650 because it is designed to be taken orally in tablet form, providing an easier, non-surgical option for patients. Additionally, its unique dosing regimens allow for a flexible and potentially more effective treatment plan. These features make BMF-650 a promising candidate in the quest for more accessible and effective obesity treatments.

What evidence suggests that BMF-650 might be an effective treatment for obesity?

Research has shown that BMF-650, a pill targeting specific receptors in the body, has helped animals lose weight. In studies, monkeys taking BMF-650 lost 12-15% of their body weight in just 28 days. They also ate less, suggesting the drug reduces appetite. This trial will explore various dosing regimens of BMF-650 to determine its effectiveness in humans. These findings indicate that BMF-650 might help people lose weight too, but further research is needed to confirm this. ^{1 3 5 6 7}

Who Is on the Research Team?

Biomea Fusion Inc.

Principal Investigator

Biomea Fusion Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who are overweight or obese. Participants should not have other significant health issues but want to explore new options for weight loss.

Inclusion Criteria

HbA1c ≤ 6.5%

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

Exclusion Criteria

Mean QTcF interval greater than 450 msec on triplicate ECGs

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of BMF-650 or placebo to evaluate safety and tolerability

6 weeks

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of BMF-650 or placebo to evaluate safety, tolerability, and pharmacokinetics

11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMF-650

Trial Overview The study tests BMF-650, a potential new treatment for obesity. It's a Phase 1 trial where participants will be randomly given either BMF-650 or a placebo without knowing which one they receive.

How Is the Trial Designed?

Group I: Part 2 MAD Cohort 4 (Regimen K) (Optional) Experimental Treatment 1 Intervention

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 II: Part 2 MAD Cohort 3 (Regimen J) Experimental Treatment 1 Intervention

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 III: Part 2 MAD Cohort 2 (Regimen I) Experimental Treatment 1 Intervention

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 IV: Part 2 MAD Cohort 1 (Regimen H) Experimental Treatment 1 Intervention

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 V: Part 1 SAD Cohort 5 (Regimen G) (Optional) Experimental Treatment 1 Intervention

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

Group VI: Part 1 SAD Cohort 4 (Regimen E and F) (Optional) Experimental Treatment 1 Intervention

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 VII: Part 1 SAD Cohort 3 (Regimen D) Experimental Treatment 1 Intervention

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

Group VIII: Part 1 SAD Cohort 2 (Regimen B and C) Experimental Treatment 1 Intervention

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 IX: Part 1 SAD Cohort 1 (Regimen A) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials

5

Recruited

780+

Citations

1. investors.biomeafusion.com investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-showcases-preclinical-advances-bmf-650-and

Biomea Fusion Showcases Preclinical Advances for BMF-650 ... BMF-650 is currently in a Phase I study in healthy obese patients with 28-day weight loss data expected in the first half of 2026. Late Breaking ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/first-patient-biomea-phase-i-bmf-650/

First patient dosed in Biomea Fusion's Phase I trial of BMF ... The Phase I study aims to evaluate BMF-650's initial efficacy, tolerability and safety in otherwise healthy individuals who are overweight or ...

3. firstwordpharma.com firstwordpharma.com/story/6509847

Biomea Fusion Announces First Patient Dosed in Phase I ... Animals receiving 10 mg/kg and 30 mg/kg doses achieved average body weight reductions of approximately 12% and 15%, respectively, from baseline.

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/biomea-fusions-bmf-650-shows-strong-weight-loss-appetite-suppression-in-preclinical-primate-study/

Biomea Fusion's BMF-650 Shows Strong Weight Loss ... Biomea Fusion announced positive preclinical results for BMF-650, an oral GLP-1 receptor agonist for obesity, in a 28-day study with obese monkeys.

5. finance.yahoo.com finance.yahoo.com/news/biomea-fusion-showcases-preclinical-advances-120000648.html

Biomea Fusion Showcases Preclinical Advances for BMF ... 12-15% body weight reduction in obese cynomolgus monkeys after 28 days of daily oral dosing. Sustained decreases in daily food intake that ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07223216

Study of BMF-650 in Otherwise Healthy Overweight or ... A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and ...

7. investors.biomeafusion.com investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-announces-first-patient-dosed-phase-i-study-bmf

Biomea Fusion Announces First Patient Dosed in Phase I ... BMF-650 was well tolerated and maintained a good safety profile. These results compare favorably with published preclinical data from another leading oral ...