Safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesity

Phase 1

• Conditions: Overweight and obesity.; Overweight and obesity

• Registration Number: IRCT20220614055167N3
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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)

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 due to endocrine disorders (eg, Cushing's syndrome)
A change in body weight of more than 5 kg within 90 days prior to screening regardless of medical record
Treatment with any medication proven to control weight within 90 days prior to screening
Treatment of obesity 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 screening
Uncontrolled thyroid disease, defined as TSH >4.78 mIU/L or 1.5 times the upper limit of normal, which is measured by the laboratory in the screening
Undertreated hypertension, defined at screening as systolic =180 mmHg or diastolic =110 mmHg
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
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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relative change of body weight compared to the base weight (%). Timepoint: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Scale.