What this trial means for you
This study is active, not recruiting. It is not currently taking new participants, but its results may matter for treatments you're considering. It's studying BMF-650 for obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Ohio
- Medpace Clinical Pharmacology, Cincinnati
View the official record on ClinicalTrials.gov →
Follow this trial
Get an email when our monthly digest covers enrollment changes and results for trials like this one.