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

August 9, 2026 updated by: Dr. Saeid Safiri, Tabriz University of Medical Sciences

Evaluation of the Safety and Efficacy and of Sodium Pentaborate Pentahydrate in People With Overweight and Obesity: a Randomized, Double-blind, Placebo-controlled Phase 1/2 Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity is considered one of the pandemics of the current century which is associated with great mortality and morbidity. In addition to changing diet and physical activity, medicines, devices, and even surgery are suggested for obesity. Although they can be effective partially, however, the rate of recurrence is high and some are invasive. So, there is a need to evaluate other types of potential interventions for obesity management. Due to the effects of boron-derivates in the prevention and management of obesity, we will evaluate the safety and efficacy of sodium pentaborate pentahydrate in patients with overweight and obesity in terms of its safety and efficacy. This study will be conducted as a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 1/2 trial. Individuals aged ≥18 years with body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of hypertension or dyslipidemia will be recruited. Participants will be randomly assigned (1:1:1:1:1:1) to oral administration of once-daily sodium pentaborate pentahydrate (200, 400, 600, 800, 1000 mg), or placebo, using balanced block randomization. The primary endpoint will be the relative change from baseline in body weight (%) at 12 weeks. Adverse events will be monitored and checked closely in terms of physical examinations and laboratory measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Iran
    • East Azarbayejan
      • Tabriz, East Azarbayejan, Iran, 5166614766
        • Imam Reza hospital and Clinic of Salamat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Capsules containing sodium pentaborate pentahydrate 200 mg
Capsules containing sodium pentaborate pentahydrate 200 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
Active Comparator: Capsules containing sodium pentaborate pentahydrate 400 mg
Capsules containing sodium pentaborate pentahydrate 400 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
Active Comparator: Capsules containing sodium pentaborate pentahydrate 600 mg
Capsules containing sodium pentaborate pentahydrate 600 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
Active Comparator: Capsules containing sodium pentaborate pentahydrate 800 mg
Capsules containing sodium pentaborate pentahydrate 800 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
Active Comparator: Capsules containing sodium pentaborate pentahydrate 1000 mg
Capsules containing sodium pentaborate pentahydrate 1000 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
Placebo Comparator: Placebo capsules
Placebo capsules of the same shape, smell, and color orally once a day
Drug: Placebo
Placebo capsules
Other Names:
  • Placebo capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of body weight
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
The relative change of body weight compared to the base weight (%)
Screening, randomization and weeks 2, 4, 6, 8, 10, 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Relative change in waist circumference compared to baseline
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in body mass index
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Relative change in body mass index compared to baseline
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change of waist to hip circumference
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Relative change of waist to hip circumference compared to baseline
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Hemoglobin A1c level
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in hemoglobin A1c level
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Fasting blood glucose
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in fasting blood glucose levels
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Insulin level
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in insulin level
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Systolic and diastolic blood pressures
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in systolic and diastolic blood pressures
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
High density lipoprotein (HDL) levels
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in high density lipoprotein (HDL) levels
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Low density lipoprotein (LDL) levels
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in low density lipoprotein (LDL) levels
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Triglyceride levels
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in triglyceride levels
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Total cholesterol levels
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in total cholesterol levels
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
High-sensitivity C-reactive protein levels
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in high-sensitivity C-reactive protein levels
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Short-Form 36 (SF-36) v2·0 acute score
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in Short-Form 36 (SF-36) v2·0 acute scores. It ranges zero to 100 and lower scores mean higher disability.
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Changes in Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2). It has four-point response scales ranging from definitely true (score = 4) to definitely false (score = 1).
Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Adverse events
Time Frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Registration of adverse events in questionnaires
Screening, randomization and weeks 2, 4, 6, 8, 10, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tabriz University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saeid Safiri, PhD, Tabriz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 70928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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