NCT06254261招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年2月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight
研究概览
简要总结
The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and < 6.5%;
- •Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
排除标准
- •Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- •with a history of diabetes or hypoglycemia;
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
- •Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
- •allergic constitution;
- •not suitable for subcutaneous injection.
研究组 & 干预措施
Placebo (cohort 2)
Placebo Comparator
Participants received Placebo administered SC once two week
干预措施: Placebo (Drug)
RAY1225 (cohort 1)
Experimental
Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.
干预措施: RAY1225 (Drug)
Placebo (cohort 1)
Placebo Comparator
Participants received Placebo administered SC once two weeks for 24 weeks.
干预措施: Placebo (Drug)
RAY1225 (cohort 2)
Experimental
Escalating doses of RAY1225 administered subcutaneously (SC) once two week
干预措施: RAY1225 (Drug)
结局指标
主要结局
Change From Baseline in Body Weight
时间窗: Baseline,Week26
Percent Change from Baseline in Body Weight
次要结局
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Baseline,Week26)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Baseline,Week26)
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Baseline,Week26)
- Change from Baseline in Waist Circumference in Centimeter(Baseline,Week26)
研究者
研究点 (1)
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