Obesity
Conditions
Keywords
Obesity, Obese, Overweight, Weight-loss, GLP-1, GLP-1 agonist, GLP-1 receptor agonist
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.
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.
Interventions
DRUGBMF-650
Interventional Product
Sponsors
Biomea Fusion Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess safety and tolerability of BMF-650 | 6 weeks (Part 1) and 11 weeks (Part 2) | Incidence of adverse events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate PK and food effect of BMF-650 in fed and fasted states | 2 weeks (Part 1) and 6 weeks (Part 2) | Tmax |
| Assess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only) | 6 weeks | Percent change in body weight compared to baseline |
Countries
United States
Contacts
STUDY_DIRECTORBiomea Fusion Inc.
Biomea Fusion Inc.
Outcome results
None listed