Safety and Efficacy of Sodium Pentaborate Pentahydrate in People With Overweight and Obesity

Exclusion Criteria

• •Glycosylated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%) as measured by the laboratory at screening.
• •History of type 1 or type 2 diabetes.
• •Treatment with glucose-lowering drug(s) within 90 days prior to screening.
• •Obesity caused by endocrine disorders (such as Cushing's syndrome)
• •Change in body weight of more than 5 kg during the 90 days before screening regardless of medical records.
• •Treatment with any drug proven to control weight in the 90 days before screening.
• •Previous or planned obesity treatment (during the trial period) with surgery or a weight loss device. However, the following are permitted: (1) liposuction and/or abdominoplasty, if performed more than one year prior to screening; (2) lap banding, if the banding was removed more than 1 year before the screening. (3) intragastric balloon, if the balloon was removed more than 1 year before the screening. or (4) duodenal-jejunal bypass sleeve, if the sleeve was removed more than 1 year before the screening.
• •Uncontrolled thyroid disease, defined as TSH \>4·78 mIU/L or 1.5 times the upper limit of normal as measured by a laboratory at screening.
• •Inadequately treated hypertension, defined at screening as systolic ≥180 mmHg or diastolic ≥110 mmHg.
• •History of malignant neoplasms in the last 5 years before the screening. Basal and squamous cell skin cancer and any in situ cancer are allowed.
• •Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disturbances.
• •The participant is currently classified as having New York Heart Association Class IV heart failure.
• •Surgery planned during the trial period, excluding minor surgery, at the discretion of the investigator.
• •Known or suspected abuse of alcohol or recreational drugs.
• •Known or suspected hypersensitivity to test product(s) or related products.
• •Participation in another clinical trial within 90 days prior to screening.
• •Personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• •Presence of acute pancreatitis within 180 days before screening.
• •History or presence of chronic pancreatitis.