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

NCT05741606 | Unknown Phase 1

• 1 other identifier: 70928
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Sodium pentaborate pentahydrate

Outcome Measures

Primary Outcomes (1)

• Change of body weight

  The relative change of body weight compared to the base weight (%)

  Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16

Secondary Outcomes (17)

• Weight loss ≥ 5% of initial body weight

  Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16

• Weight loss ≥ 10% of initial body weight

  Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16

• Change in waist circumference

  Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16

• Change in body mass index

  Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16

• Change of waist to hip circumference

  Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16

Study Arms (6)

Capsules containing sodium pentaborate pentahydrate 200 mg

ACTIVE COMPARATOR

Capsules containing sodium pentaborate pentahydrate 200 mg orally once a day

Drug: Sodium pentaborate pentahydrate

Capsules containing sodium pentaborate pentahydrate 400 mg

ACTIVE COMPARATOR

Capsules containing sodium pentaborate pentahydrate 400 mg orally once a day

Drug: Sodium pentaborate pentahydrate

Capsules containing sodium pentaborate pentahydrate 600 mg

ACTIVE COMPARATOR

Capsules containing sodium pentaborate pentahydrate 600 mg orally once a day

Drug: Sodium pentaborate pentahydrate

Capsules containing sodium pentaborate pentahydrate 800 mg

ACTIVE COMPARATOR

Capsules containing sodium pentaborate pentahydrate 800 mg orally once a day

Drug: Sodium pentaborate pentahydrate

Capsules containing sodium pentaborate pentahydrate 1000 mg

ACTIVE COMPARATOR

Capsules containing sodium pentaborate pentahydrate 1000 mg orally once a day

Drug: Sodium pentaborate pentahydrate

Placebo capsules

PLACEBO COMPARATOR

Placebo capsules of the same shape, smell, and color orally once a day

Drug: Placebo

Interventions

Sodium pentaborate pentahydrate DRUG

Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg

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

Placebo DRUG

Placebo capsules

Also known as: Placebo capsules

Placebo capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

Study Sites (1)

Imam Reza hospital and Clinic of Salamat

Tabriz, East Azarbayejan, 5166614766, Iran

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Saeid Safiri, PhD

  Tabriz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saeid Safiri, PhD

CONTACT

+984133342178; saeidsafiri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: July 21, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 21, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)