NCT07671391尚未招募2 期
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants
Shanghai Zhongshan Hospital0 个研究点目标入组 60 人开始时间: 2026年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- The percentage change in lean body mass
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled trial aimed at exploring the effects of LAE102 injection in combination with Tirzepatide on body composition.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study and sign the Informed Consent Form (ICF);
- •Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;
- •BMI ranging from 28.0 to 40.0 kg/m2 during the screening;
- •Self-reporting at least one experience of weight loss failure after adjusting diet and exercise, and within the previous 3 months, the weight change after only dietary and exercise adjustments was less than 5%;
排除标准
- •A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes);
- •Screening criteria: Glycated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L.
- •Obesity related:
- •Diagnosed with secondary obesity;
- •Previously underwent surgical or endoscopic weight loss metabolic surgery (except for local liposuction within 1 year before screening) or gastric balloon implantation, or planned to undergo any weight loss surgery or receive other weight loss treatments during the study;
- •Uncontrolled thyroid disease, or screening criteria.
结局指标
主要结局
The percentage change in lean body mass
时间窗: 24 weeks
At 24 weeks of treatment, the lean body mass measured by dual-energy X-ray absorptiometry (DXA) compared to the baseline percentage change
次要结局
- Effectiveness endpoint(24 weeks)
- Safety endpoint(24 weeks)
研究者
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