NCT07281495进行中（未招募）2 期
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With Open-Label Extension to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Taldefgrobep Alfa in Adults Living With Overweight and Obesity
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 35
- 主要终点
- Percent change in total body weight from Baseline to Week 24
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, multiple dose study to evaluate the efficacy, safety, and tolerability of taldefgrobep alfa in adults with overweight and obesity, with an open-label extension.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. BMI > 30 kg/m2 and BMI < 42 kg/m2, OR b. BMI ≥ 27 kg/m2 and BMI <30 kg/m2 with at least one weight-related co-morbidity
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
- •Stable body weight and stable physical activity within 3 months prior to screening per participant self-report.
- •All participants must adhere to protocol contraception requirements
排除标准
- •History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening
- •Non-ambulatory participants, defined as unable to take at least 10 steps independently.
- •Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed.
- •Participation in another investigational clinical trial while participating in this clinical trial
研究组 & 干预措施
Taldefgrobep Alpha once weekly
Experimental
干预措施: Taldefgrobep Alfa (Drug)
Placebo once weekly
Placebo Comparator
干预措施: Placebo (Drug)
Taldefgrobep Alpha once every 4 weeks
Experimental
干预措施: Taldefgrobep Alfa (Drug)
Placebo once every 4 weeks
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in total body weight from Baseline to Week 24
时间窗: Baseline to Week 24
次要结局
- Percent change in total body fat mass from Baseline to Week 24(Baseline to Week 24)
- Percent change in total body lean mass from Baseline to Week 24(Baseline to Week 24)
- Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities(Through week 24)
研究者
研究点 (35)
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