NCT07104500进行中（未招募）3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,500
- 试验地点
- 137
- 主要终点
- Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
研究概览
简要总结
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
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
- 否
入选标准
- •Age ≥18 years of age at the time of signing the informed consent
- •Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)
- •Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
- •Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
- •BMI calculated at the Screening visit will be used to determine eligibility
排除标准
- •History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
- •Self-reported body weight change of 5% or more within 3 months of screening
- •Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
- •Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
- •Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
- •Treatment with glucose-lowering agent(s) within 90 days before screening
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- •History of acute or chronic pancreatitis
研究组 & 干预措施
Placebo Assignment
Placebo Comparator
VK2735 Placebo Comparator Once Weekly
干预措施: VK2735 (Drug)
Active Assignment (Dose 1)
Experimental
VK2735 7.5mg Once Weekly
干预措施: VK2735 (Drug)
Active Assignment (Dose 2)
Experimental
VK2735 12.5mg Once Weekly
干预措施: VK2735 (Drug)
Active Assignment (Dose 3)
Experimental
VK2735 17.5mg Once Weekly
干预措施: VK2735 (Drug)
结局指标
主要结局
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
时间窗: 78 Weeks
次要结局
- Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment(78 Weeks)
研究者
研究点 (137)
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