Overweight and ObesityPhase 1/2NCT05741606
Safety and Efficacy of Sodium Pentaborate Pentahydrate in People With Overweight and Obesity
A Phase 1/2 study testing Sodium pentaborate pentahydrate in people with Overweight and Obesity, run by Tabriz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Sodium pentaborate pentahydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2024to 21 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Imam Reza hospital and Clinic of Salamat
Tabriz, East Azarbayejan, 5166614766
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Sodium pentaborate pentahydrate, Placebo
- Keywords
- Overweight, Obesity, Sodium pentaborate pentahydrate
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium pentaborate pentahydrateDrug
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
PlaceboDrug
Also called Placebo capsules
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Capsules containing sodium pentaborate pentahydrate 200 mg | Active comparator | Capsules containing sodium pentaborate pentahydrate 200 mg orally once a day Receives: Drug: Sodium pentaborate pentahydrate |
| Capsules containing sodium pentaborate pentahydrate 400 mg | Active comparator | Capsules containing sodium pentaborate pentahydrate 400 mg orally once a day Receives: Drug: Sodium pentaborate pentahydrate |
| Capsules containing sodium pentaborate pentahydrate 600 mg | Active comparator | Capsules containing sodium pentaborate pentahydrate 600 mg orally once a day Receives: Drug: Sodium pentaborate pentahydrate |
| Capsules containing sodium pentaborate pentahydrate 800 mg | Active comparator | Capsules containing sodium pentaborate pentahydrate 800 mg orally once a day Receives: Drug: Sodium pentaborate pentahydrate |
| Capsules containing sodium pentaborate pentahydrate 1000 mg | Active comparator | Capsules containing sodium pentaborate pentahydrate 1000 mg orally once a day Receives: Drug: Sodium pentaborate pentahydrate |
| Placebo capsules | Placebo comparator | Placebo capsules of the same shape, smell, and color orally once a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body weight
The relative change of body weight compared to the base weight (%)
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Secondary outcomes (15)
Change in waist circumference
Relative change in waist circumference compared to baseline
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in body mass index
Relative change in body mass index compared to baseline
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change of waist to hip circumference
Relative change of waist to hip circumference compared to baseline
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Hemoglobin A1c level
Change in hemoglobin A1c level
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Fasting blood glucose
Change in fasting blood glucose levels
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Insulin level
Change in insulin level
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Systolic and diastolic blood pressures
Changes in systolic and diastolic blood pressures
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
High density lipoprotein (HDL) levels
Changes in high density lipoprotein (HDL) levels
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Low density lipoprotein (LDL) levels
Changes in low density lipoprotein (LDL) levels
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Triglyceride levels
Changes in triglyceride levels
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Total cholesterol levels
Changes in total cholesterol levels
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
High-sensitivity C-reactive protein levels
Changes in high-sensitivity C-reactive protein levels
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Short-Form 36 (SF-36) v2·0 acute score
Changes in Short-Form 36 (SF-36) v2·0 acute scores. It ranges zero to 100 and lower scores mean higher disability.
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)
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).
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Adverse events
Registration of adverse events in questionnaires
Measured: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jul 2024
- Primary completion20 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saeid Safiri, Tabriz University of Medical Sciences
- Investigators
- Saeid Safiri, PhD, Principal investigator, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741606
- Sponsor's protocol ID
- 70928
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05741606
- Acronym / sponsor ID
- 70928
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Sodium pentaborate pentahydrate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Capsules containing sodium pentaborate pentahydrate 200 mg | Active comparator | Drug: Sodium pentaborate pentahydrateCapsules containing sodium pentaborate pentahydrate 200 mg orally once a day |
| Capsules containing sodium pentaborate pentahydrate 400 mg | Active comparator | Drug: Sodium pentaborate pentahydrateCapsules containing sodium pentaborate pentahydrate 400 mg orally once a day |
| Capsules containing sodium pentaborate pentahydrate 600 mg | Active comparator | Drug: Sodium pentaborate pentahydrateCapsules containing sodium pentaborate pentahydrate 600 mg orally once a day |
| Capsules containing sodium pentaborate pentahydrate 800 mg | Active comparator | Drug: Sodium pentaborate pentahydrateCapsules containing sodium pentaborate pentahydrate 800 mg orally once a day |
| Capsules containing sodium pentaborate pentahydrate 1000 mg | Active comparator | Drug: Sodium pentaborate pentahydrateCapsules containing sodium pentaborate pentahydrate 1000 mg orally once a day |
| Placebo capsules | Placebo comparator | Drug: PlaceboPlacebo capsules of the same shape, smell, and color orally once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium pentaborate pentahydrateCapsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg | Drug | Capsules containing sodium pentaborate pentahydrate 1000 mg, Capsules containing sodium pentaborate pentahydrate 200 mg, Capsules containing sodium pentaborate pentahydrate 400 mg, Capsules containing sodium pentaborate pentahydrate 600 mg, Capsules containing sodium pentaborate pentahydrate 800 mg |
| PlaceboAlso: Placebo capsulesPlacebo capsules | Drug | Placebo capsules |
Primary outcome
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 (%)
15 secondary outcomes
Change in waist circumference
Time frame: 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
Change of waist to hip circumference
Time frame: 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
Fasting blood glucose
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Insulin level
Time frame: 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
High density lipoprotein (HDL) levels
Time frame: 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
Triglyceride levels
Time frame: 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
High-sensitivity C-reactive protein levels
Time frame: 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
Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Adverse events
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saeid Safiri, PhD principal investigator
Tabriz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sodium pentaborate pentahydrate in people with Overweight and Obesity, run by Tabriz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body weight (time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.