NCT06530017尚未招募不适用
A Prospective, Multicenter, Randomized, Double-blind, Parallel Controlled, and Superiority Clinical Trial to Evaluate the Effectiveness and Safety of Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 440
- 试验地点
- 11
- 主要终点
- Response rate of weight loss at week 24 after enrollment
研究概览
简要总结
To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment
详细描述
Ingested, Space Occupying hydrogel capsules is indicated to aid in simple obesity treatment with a Body Mass Index (BMI) of 28-40 kg/m2，using under the guidance of a physician.This clinical trial seek to evaluate the efficacy and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects have a BMI≥28kg/m²and BMI≤40kg/m²
排除标准
- •Individuals with secondary obesity, such as hypothyroidism, Cushing's syndrome, etc.
- •Those who have undergo surgical method within the past 3 months prior to screening, or plan to lose weight by surgical method during the clinical trial.
- •Weight loss exceeding >5% (self-report) within the past 3 months prior to screening.
- •Individuals with uncontrolled diabetes mellitus (fasting blood glucose≥7.0mmol/L or glucose loading after 2 hours blood glucose≥11.1mmol/L or glycosylated hemoglobin≥7.0%) .
- •Within 1 month before screening or planning to use drugs or health products that may cause significant weight gain or loss during the clinical trials, including biguanides,α-glycosidase inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, leptinoid drugs, sympathomimetic drugs, esterase inhibitors, lipolytic injections, sulfonamides, systemic glucocorticoids (more than 1 week), estrogen, thyroid hormones or preparations, antipsychotic or antidepressant drugs, Chinese patent medicines and Chinese herbal medicines, etc.
- •Patients with central nervous system diseases (including but not limited to any type of seizures or strokes) and other related neurological diseases or mental illnesses.
- •Those who have suffered or are suffering from swallowing disorders, gastroesophageal reflux disease, gastric or duodenal ulcers, gastroparesis, esophageal and gastric varices, intestinal obstruction or suspected small bowel adhesions, pyloric obstruction, Crohn's disease, ulcerative colitis and other diseases, acute/chronic pancreatitis, as well as a history of gastrointestinal surgery (except those related to appendectomy and intestinal polypectomy), abdominal radiation therapy, and gastrointestinal bleeding.
- •Those who have AIDS or a history of cancer within the past 5 years.
- •Patients with poorly controlled hypertension, i.e., systolic blood pressure (SBP) > 165mmHg and/or diastolic blood pressure (DBP) >95mmHg.
- •Patients with renal insufficiency, i.e., estimated glomerular filtration rate (eGFR<30 ml/min/1.73m2)* calculated by the CKD-EPI creatinine equation as defined by the KDIGO 2012 classification.
- •Patients with impaired liver function, that is, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or total bilirubin (TBIL) > 3 times the upper limit of normal.
- •Those who stop smoking within the past 6 months before the screening period or consider stop smoking during the trial.
- •Those who have planned surgery in the past 6 months.
- •Pregnant or breastfeeding, planning to become pregnant during the trial (or males unwilling to use an adequate method of contraception), or having a positive pregnancy test result during the screening period.
- •Individuals with a history of allergies to cellulose, titanium dioxide, citrate acid and succinic acid.
- •Those with severe cardiovascular and cerebrovascular diseases or systemic failure that affects treatment.
- •The investigator judges that the subject has other systemic diseases that are not suitable for participating in this trial, and the abnormal laboratory test results are determined by the investigator whether they can be enrolled.
- •Participated in clinical trials of other drugs or medical devices within 30 days prior to the screening period.
- •Other circumstances that the investigator deems inappropriate to participate in this trial.
结局指标
主要结局
Response rate of weight loss at week 24 after enrollment
时间窗: 24 weeks
Calculation formula:Weight loss response rate = Number of subjects with ≥5% weight loss percentage from baseline/total number of subjects ×100%.
Weight loss percentage from baseline at Week 24
时间窗: 24 weeks
Calculation formula:Weight loss percentage from baseline = (weight at Week 24 after enrollment of subject - baseline weight) / baseline weight×100%
次要结局
未报告次要终点
研究者
研究点 (11)
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