NCT06939296进行中（未招募）3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VCT220 Tablets in Overweight or Obese Participants
Vincentage Pharma Co., Ltd1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2024年12月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in body weight
研究概览
简要总结
The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, both male and female;
- •At screening, BMI ≥ 28 kg/m² or 24 kg/m² ≤ BMI < 28 kg/m² with at least one of the following conditions:
- •Comorbid prediabetes (impaired fasting glucose and/or abnormal glucose tolerance), hypertension, dyslipidemia, or fatty liver (within the past 6 months prior to screening);
- •Comorbid weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases);
- •Obesity-related shortness of breath or obstructive sleep apnea syndrome;
- •Weight change during the past 3 months due to diet and exercise control should not exceed 5% (self-reported); weight change calculation formula: (highest weight - lowest weight in the past 3 months) / highest weight * 100%;
- •Willing and able to maintain a stable diet and exercise regimen throughout the study;
- •Fully understands the purpose of the study, able to communicate well with the investigator, can comprehend and comply with the requirements of this study, and is willing to sign the informed consent form
排除标准
- •Patients with type 1, type 2, or other types of diabetes.
- •A history of endocrine diseases or obesity caused by single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, and hypogonadism.
- •A history of weight-loss surgery (except for liposuction performed more than 1 year ago) or plans to undergo weight-loss surgery, use weight-loss devices, or medical equipment during the study.
- •Has used any of the following medications or treatments:
- •Has previously used any GLP-1 receptor agonists (GLP-1RAs), GLP-1-related multi-target agonists (such as GLP-1/glucose-dependent insulinotropic peptide [GIP] dual receptor agonists, GLP-1 receptor/glucagon receptor [GCGR] dual agonists, GLP-1/GIP/glucagon [GCG] triple receptor agonists, etc.), or combination formulations containing GLP-1RAs (such as exenatide, liraglutide, semaglutide, benaglutide, etc.);
- •Within the past 6 months prior to screening, has used any approved or unapproved weight-loss medications other than GLP-1 receptor agonists (GLP-1RAs) and GLP-1-related multi-target agonists (such as orlistat, phentermine/topiramate, naltrexone/bupropion, etc.), or weight-affecting herbal medicines, supplements, meal replacements, etc.;
- •Within the past 3 months prior to screening, has used any antidiabetic medications, such as metformin, α-glucosidase inhibitors, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), etc.;
- •Within the past 3 months prior to screening, has used any medications that may cause significant weight gain, including systemic corticosteroid treatment for more than 1 week, tricyclic antidepressants, antipsychotic or anticonvulsant medications (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts, methyldopa, etc.).
研究组 & 干预措施
High dose group
Experimental
Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose.
干预措施: VCT220 (Drug)
Moderate dose group
Experimental
Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose.
干预措施: VCT220 (Drug)
Placebo group
Placebo Comparator
Participants will receive placebo tablets orally, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change from baseline in body weight
时间窗: From baseline to week 34
The proportion of subjects with a body weight reduction ≥5% from baseline
时间窗: From baseline to week 34
次要结局
- Percentage change from baseline in body mass index (BMI)(From baseline to week 52)
- Percentage change from baseline in blood lipid profiles(From baseline to week 52)
- Percentage change from baseline in waist circumference(From baseline to week 52)
- Percentage change from baseline in body weight(From baseline to week 52)
- The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%(From baseline to week 34 and week 52)
- The proportion of subjects with a body weight reduction of ≥5% from baseline(From baseline to week 52)
- Percentage change from baseline in blood pressure(From baseline to week 52)
- Percentage change from baseline in fasting plasma glucose(From baseline to week 52)
- Percentage change from baseline in fasting insulin(From baseline to week 52)
- Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)(From baseline to week 52)
- Improvement in quality of life(From baseline to week 52)
研究者
研究点 (1)
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