NCT01963598已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
- 主要终点
- Percent change in total lean body mass
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 70 years and older (all women participating in the study must be postmenopausal)
- •Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions
- •Ability to follow a walking program
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
- •Able to understand and complete study-related questionnaires
排除标准
- •Hospitalization or immobilization with a duration of >48 hours within the month prior to screening
- •Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
- •Participate in resistance training more than 3 times per week and regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
- •Chronic medications introduced within 2 weeks prior to screening
- •Respiratory disease that requires oxygen treatment
- •Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
- •Neurological conditions that are causing impaired muscle function or mobility
- •Certain cardiovascular conditions
- •Uncontrolled diabetes
- •The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
研究组 & 干预措施
Group 2
Experimental
Dosing regimen 2
干预措施: REGN1033 (SAR391786) (Drug)
Group 2
Experimental
Dosing regimen 2
干预措施: placebo (Drug)
Group 3
Experimental
Dosing regimen 3
干预措施: REGN1033 (SAR391786) (Drug)
Group 3
Experimental
Dosing regimen 3
干预措施: placebo (Drug)
Group 4
Experimental
Dosing regimen 4
干预措施: placebo (Drug)
Group 1
Experimental
Dosing regimen 1
干预措施: REGN1033 (SAR391786) (Drug)
结局指标
主要结局
Percent change in total lean body mass
时间窗: day 1 to day 85
The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85).
次要结局
- Change in appendicular lean mass(day 1 to day 141)
- TEAEs(day 1 to day 141)
- Change in maximal leg press strength (1-RM)(day 1 to day 141)
- Change in maximal chest press strength (1-RM)(day 1 to day 141)
- Change in 4M gait speed(day 1 to day 141)
- Change in SPPB subscores(day 1 to day 141)
- Change in distance walked in the 6MWT(day 1 to day 141)
- Change in regional and total fat mass by DEXA(day 1 to day 141)
- Change in hand grip strength by handheld dynamometer(day 1 to day 141)
- Change in unloaded and loaded stair climb power(day 1 to day 141)
研究者
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