Clinical trial NCT05741606: Safety and Efficacy of Sodium Pentaborate Pentahydrate in People With Overweight and Obesity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Sodium pentaborate pentahydrate
Lead sponsor: Tabriz University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 (6:1) 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of body weight
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
Secondary outcomes:
measure: Weight loss ≥ 5% of initial body weight
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Weight loss ≥ 10% of initial body weight
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Change in waist circumference
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Change in body mass index
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Change of waist to hip circumference
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Hemoglobin A1c level
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Fasting blood glucose
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Insulin level
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Systolic and diastolic blood pressures
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: High density lipoprotein (HDL) levels
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Low density lipoprotein (LDL) levels
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Triglyceride levels
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Total cholesterol levels
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: High-sensitivity C-reactive protein levels
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Short-Form 36 (SF-36) v2·0 acute score
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
measure: Adverse events
timeFrame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Imam Reza hospital and Clinic of Salamat
state: East Azarbayejan
Study officials:
affiliation: Tabriz University of Medical Sciences
name: Saeid Safiri, PhD
role: PRINCIPAL_INVESTIGATOR
References: