A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 15
- 主要终点
- Percent (relative) change from baseline in body weight after 13 weeks of treatment
研究概览
简要总结
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
VK2735 or matched placebo will be administered once daily.
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), and BMI <50 kg/m2
- •Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
- •BMI calculated at the Screening visit will be used to determine eligibility.
排除标准
- •History of or current clinically significant medical or psychiatric 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
- •Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
- •Current or past diagnosis of chronic pancreatitis
- •Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
- •Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
- •Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
研究组 & 干预措施
Placebo Assignment
VK2735 (Placebo) administered Daily
干预措施: Placebo (Drug)
Active Assignment (Dose #1)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
干预措施: VK2735 (Drug)
Active Assignment (Dose #2)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
干预措施: VK2735 (Drug)
Active Assignment (Dose #3)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
干预措施: VK2735 (Drug)
Active Assignment (Dose #4)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
干预措施: VK2735 (Drug)
Active Assignment (Dose #5)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
干预措施: VK2735 (Drug)
Active Assignment (Dose #6)
VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
干预措施: VK2735 (Drug)
结局指标
主要结局
Percent (relative) change from baseline in body weight after 13 weeks of treatment
时间窗: 13 Weeks
To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
次要结局
- Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment(13 Weeks)