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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Change of body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Capsules containing sodium pentaborate pentahydrate 200 mg
Capsules containing sodium pentaborate pentahydrate 200 mg orally once a day
干预措施: Sodium pentaborate pentahydrate (Drug)
Placebo capsules
Placebo capsules of the same shape, smell, and color orally once a day
干预措施: Placebo (Drug)
Capsules containing sodium pentaborate pentahydrate 800 mg
Capsules containing sodium pentaborate pentahydrate 800 mg orally once a day
干预措施: Sodium pentaborate pentahydrate (Drug)
Capsules containing sodium pentaborate pentahydrate 600 mg
Capsules containing sodium pentaborate pentahydrate 600 mg orally once a day
干预措施: Sodium pentaborate pentahydrate (Drug)
Capsules containing sodium pentaborate pentahydrate 1000 mg
Capsules containing sodium pentaborate pentahydrate 1000 mg orally once a day
干预措施: Sodium pentaborate pentahydrate (Drug)
Capsules containing sodium pentaborate pentahydrate 400 mg
Capsules containing sodium pentaborate pentahydrate 400 mg orally once a day
干预措施: Sodium pentaborate pentahydrate (Drug)
结局指标
主要结局
Change of body weight
时间窗: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16
The relative change of body weight compared to the base weight (%)
Change of body weight
时间窗: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
The relative change of body weight compared to the base weight (%)
次要结局
- 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)
- Hemoglobin A1c level(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Fasting blood glucose(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Insulin level(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Systolic and diastolic blood pressures(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- High density lipoprotein (HDL) levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Low density lipoprotein (LDL) levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Triglyceride levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Total cholesterol levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- High-sensitivity C-reactive protein levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Weight loss ≥ 5% of initial body weight(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Short-Form 36 (SF-36) v2·0 acute score(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)(Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16)
- Adverse events(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)
- Hemoglobin A1c level(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Change in waist circumference(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Change in body mass index(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Fasting blood glucose(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Insulin level(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Systolic and diastolic blood pressures(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- High density lipoprotein (HDL) levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Low density lipoprotein (LDL) levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Triglyceride levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Total cholesterol levels(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- 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(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
- Adverse events(Screening, randomization and weeks 2, 4, 6, 8, 10, 12)
研究者
Dr. Saeid Safiri
Principal Investigator
Tabriz University of Medical Sciences