A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
研究概览
简要总结
The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults 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
- •Low muscle mass as confirmed by DXA;
- •Low gait speed <0.8 m/s
- •SPPB score less than or equal to 9;
- •Weigh at least 35 kg;
- •Adequate dietary intake;
排除标准
- •A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management);
- •Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting).
- •Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening;
- •Any underlying muscle disease including active myopathy or muscular dytrophy;
- •Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy);
- •Type I diabetes or uncontrolled Type 2 diabetes;
- •Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];
- •History of confirmed chronic obstructive pulmonary disease with a severity grade > 2 on the Medical Research Council Dyspnea Scale;
- •Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/d prednisone equivalent;
- •Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis);
- •Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening;
- •Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix);
- •Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc).
研究组 & 干预措施
BYM338 70 mg
BYM338 70 mg intravenous infusion
干预措施: bimagrumab (Drug)
BYM338 210 mg
BYM338 210 mg intravenous infusion
干预措施: bimagrumab (Drug)
BYM338 700 mg
BYM338 700 mg intravenous infusion
干预措施: bimagrumab (Drug)
Placebo
Placebo intravenous infusion
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
时间窗: Baseline, week 25
Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
次要结局
- Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance(Baseline, week 25)
- Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters(baseline, week 25)
- Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)(baseline, week 25)
- Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)(baseline, week 25)