NCT01604408已完成2 期
A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness
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
- 201
- 试验地点
- 1
- 主要终点
- Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)
研究概览
简要总结
LY2495655 is an investigational drug being tested for muscle wasting.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained at least 1 fall within 1 calendar year before study screening.
- •Requires ≥12 seconds to perform a repeated chair stands test or is unable to complete this test at screening.
- •Hand grip strength is ≤37 kilograms (kg) for men (81.4 pounds) or ≤21 kg for women (46.2 pounds) at screening.
- •Can stand up from a chair and walk ≥10 meters without human assistance (gait aids such as cane[s], crutches, or walkers are acceptable) at screening.
- •Able to climb at least 1 step on a staircase without human assistance according to the participant at screening (using handrails is allowed).
- •Have screening clinical laboratory test results within normal reference range for the population, or have results with acceptable deviations that are judged to be not clinically significant by the investigator.
排除标准
- •Major lower limb pain or neurologic impairment or vestibular vertigo or visual impairment that could severely confound measures of physical performance.
- •Recent lower limb fracture and/or major lower limb surgery.
- •Planned major surgical procedure within 6 months following study drug dosing.
- •Have had a lower extremity amputation of the foot, leg, and/or thigh.
- •Have a body mass index (BMI) ≥35 kilogram per meter squared (kg/m2).
- •Severe vitamin D deficiency.
- •Underlying muscle disease other than age-associated muscle waste or disuse atrophy.
- •Current use or previous use of any drugs known to influence muscle mass or performance.
- •Have had a recent neurologic injury (<6 months before study drug dosing), such as stroke or spinal cord injury.
- •History of a malignant neoplasm in the 18 months before first study drug dosing.
- •Have a history or presence of unstable cardiovascular or pulmonary comorbidities.
- •Have a positive fecal occult blood (FOB) test at screening, or the participant cannot provide a stool sample for FOB testing before first study drug dosing.
- •Have either severe ongoing liver disease or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times upper limit of normal (ULN), alkaline phosphatase (ALP) >1.5 times ULN, or total bilirubin >1.5 times ULN at screening.
- •Have an estimated creatinine clearance <20 milliliters per minute (mL/minute).
- •Have a history of severe allergic reaction to a monoclonal antibody.
- •Are males with a female partner of childbearing potential who do not agree to use contraception during the treatment period of the study and up to 15 weeks after the last dose of investigational product (study drug).
- •Have known allergies to LY2495655, its constituents, or related compounds.
- •Have severe active psychiatric disease or cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) score <22 (for a participant who went to school up to age 15 years or less) or <24 (for a participant who went to school up to at least age 16), making the participant unlikely to understand the informed consent form or comply with protocol procedures.
- •Exhibit excessive consumption of alcohol or abuse of drugs.
- •Have uncontrolled diabetes mellitus.
- •Have had ocular trauma, ophthalmologic surgery, or eye laser treatment within 6 months before study drug dosing.
- •Have hyponatremia (serum sodium levels <135 millimoles/liter ([mmol/L]) at screening unless a retest shows normonatremia before study drug dosing.
研究组 & 干预措施
LY2495655
Experimental
Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
干预措施: LY2495655 (Biological)
Placebo
Placebo Comparator
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)
时间窗: Baseline to 24 weeks
Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.
次要结局
- Change From Baseline in Repeated Chair Stands (RCS) Time(Baseline to 24 weeks)
- Change From Baseline in Usual Gait Speed (uGS) at 4 Meters(Baseline to 24 weeks)
- Change From Baseline in Stair Climbing (StC) Time(Baseline to 24 weeks)
研究者
研究点 (1)
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