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A Study in Older Participants Who Have Fallen and Have Muscle Weakness

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ClinicalTrials.gov Identifier: NCT01604408
Recruitment Status : Completed
First Posted : May 23, 2012
Results First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
LY2495655 is an investigational drug being tested for muscle wasting.

Condition or disease Intervention/treatment Phase
Muscle Weakness Biological: LY2495655 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: LY2495655
Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
Biological: LY2495655
Administered SC

Placebo Comparator: Placebo
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change From Baseline in Stair Climbing (StC) Time [ Time Frame: Baseline to 24 weeks ]
    Change from baseline to the 24-week endpoint in StC time is presented. StC time was assessed by measuring the fastest time achieved to climb 4 steps on a 4-step staircase (the test was performed 2 times). LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline StC score as covariate.

  2. Change From Baseline in Repeated Chair Stands (RCS) Time [ Time Frame: Baseline to 24 weeks ]
    Change from baseline to 24-week endpoint in RCS time is presented. In the RCS test, participants were asked to rise from a chair 5 times as fast as possible with their arms folded on their chest. Performance was measured in seconds, as the time from the initial seated position to the final standing position. LS means were calculated using an MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline RCS time as covariate.

  3. Change From Baseline in Usual Gait Speed (uGS) at 4 Meters [ Time Frame: Baseline to 24 weeks ]
    Change from baseline to the 24-week endpoint in uGS is presented. Two attempts to walk a 4-meter distance were made. LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline uGS as covariate.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604408


Locations
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aurora, Colorado, United States, 80045
United States, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gainesville, Georgia, United States, 30501
United States, Massachusetts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston, Massachusetts, United States, 02131
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Louis, Missouri, United States, 63108
United States, North Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winston-Salem, North Carolina, United States, 27157
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Galveston, Texas, United States, 77555
United States, Wisconsin
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, United States, 53705
Argentina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, Argentina, C1128AAF
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Caba, Argentina, 1405
Australia, New South Wales
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hornsby, New South Wales, Australia, 2077
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kingswood, New South Wales, Australia, 2747
Australia, South Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daw Park, South Australia, Australia, 5041
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montpellier, France, 34295
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, France, 75013
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pessac, France, 33604
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pierre Benite, France, 69495
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toulouse, France, TSA 60033
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Köln, Germany, 50668
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stuttgart, Germany, 70376
Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huddinge, Sweden, 14186
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mölndal, Sweden, 43180
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Uppsala, Sweden, 75185
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01604408     History of Changes
Other Study ID Numbers: 14499
I1Q-MC-JDDJ ( Other Identifier: Eli Lilly and Company )
First Posted: May 23, 2012    Key Record Dates
Results First Posted: April 25, 2018
Last Update Posted: April 25, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms