NCT07324850尚未招募1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-7342 in Subjects With Obesity or Overweight
Suzhou Sanegene Bio Inc.0 个研究点目标入组 45 人开始时间: 2026年1月12日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of subcutaneously administered SGB-7342 in adult subjects with obesity and overweight.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) within the range of 26.0 to 35.0 kg/m²
- •Have a stable body weight within 3 months
- •Participants must agree to use adequate contraception from signing the informed consent until 6 months after completion of the follow-up visit.
- •Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.
排除标准
- •A history of or a current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.
- •Use of GLP-1R agonists for any indication within 6 months prior to administering the investigational drug.
- •Use of non-GLP1R medications for weight loss within 3 months prior to administering the investigational drug.
- •Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST)> 1.5 × ULN, and deemed clinically significant by the Investigators
研究组 & 干预措施
SGB-7342
Experimental
干预措施: SGB-7342 (Drug)
SGB-7342-Matching placebo
Placebo Comparator
干预措施: SGB-7342-Matching placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: up to approximately 6 months
次要结局
- Maximum Observed Plasma Concentration (Cmax)(up to approximately 3 days)
- Area Under the Concentration-time Curve (AUC)(up to 3 days)
- Weight change from baseline(up to approximately 12 months)
研究者
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