Safety and Efficacy of Sodium Pentaborate Pentahydrate in People With Overweight and Obesity (NCT05741606) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy of Sodium Pentaborate Pentahydrate in People With Overweight and Obesity
Iran177 participantsStarted 2024-07-01
Plain-language summary
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in improving the body weight and glycemic profile of patients with overweight or obesity compared to the placebo group.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.