IRCT20220614055167N3尚未招募1 期
Evaluation of the safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesity: a randomised, double-blind, placebo-controlled phase 1/2 trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
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 due to endocrine disorders (eg, Cushing's syndrome)
- •A change in body weight of more than 5 kg within 90 days prior to screening regardless of medical record
- •Treatment with any medication proven to control weight within 90 days prior to screening
- •Treatment of obesity 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 screening
- •Uncontrolled thyroid disease, defined as TSH >4.78 mIU/L or 1.5 times the upper limit of normal, which is measured by the laboratory in the screening
- •Undertreated hypertension, defined at screening as systolic =180 mmHg or diastolic =110 mmHg
- •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.
研究者
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