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

Prior treatment

• 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.
• Surgery planned during the trial period, excluding minor surgery, at the discretion of the investigator.
• Known or suspected abuse of alcohol or recreational drugs.
• Participation in another clinical trial within 90 days prior to screening.
• Presence of acute pancreatitis within 180 days before screening.

Other illness

• History of type 1 or type 2 diabetes.
• Obesity caused by endocrine disorders (such as Cushing's syndrome)
• 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.
• Known or suspected hypersensitivity to test product(s) or related products.
• Personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• Any impairment, unwillingness, or disability, not covered by any of the other exclusion criteria, that in the opinion of the investigator may compromise the participant's safety or compliance with the protocol.

Lab values

• Glycosylated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%) as measured by the laboratory at screening.
• Treatment with glucose-lowering drug(s) within 90 days prior to 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.

Other

• History or presence of chronic pancreatitis.

• Age ≥18 years at the time of signing the informed consent.
• A non-pregnant female participant or a male participant who has been surgically sterilized (vasectomy) or is willing to use appropriate contraceptive methods during the trial (until the end of the trial).
• Body mass index (BMI) ≥30·0 kg/m2 or BMI ≥27·0 kg/m2 in the presence of hypertension or dyslipidemia (treated or untreated, assessed at the discretion of the investigator).