New obesity drug BMF-650 enters first human safety trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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