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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01604408
First received: May 21, 2012
Last updated: April 14, 2014
Last verified: December 2013
  Purpose

LY2495655 is an investigational drug being tested for muscle wasting. Muscle wasting includes shrinking of the muscle and weakness. This can occur when a muscle is no longer as active as usual. When muscles are no longer in use, they become weaker.


Condition Intervention Phase
Muscle Weakness
Biological: LY2495655
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to 24 week endpoint in appendicular Lean Body Mass (aLBM) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Stair Climbing (StC) Score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Repeated Chair Stands (RCS) Score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Usual Gait Speed (uGS) at 4 Meters [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2495655
315 mg administered as three Subcutaneous (SQ) injections every 4 weeks for 20 weeks
Biological: LY2495655
Administered SQ
Placebo Comparator: Placebo
Administered as three SQ injections every 4 weeks for 20 weeks
Drug: Placebo
Administered SQ

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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 are acceptable such as cane[s], crutches, or walker) 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 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), or alkaline phosphatase (ALP) >1.5 times ULN, or total bilirubin >1.5 times ULN at screening.
  • Have an estimated creatinine clearance <20 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 Mini-Mental State Examination ([MMSE] <24) making the participant unlikely to understand the informed consent form or comply with protocol procedures.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
St 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
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Madison, Wisconsin, United States, 53705
Argentina
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Buenos Aires, Argentina, C1128AAF
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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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01604408     History of Changes
Other Study ID Numbers: 14499, I1Q-MC-JDDJ
Study First Received: May 21, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
France: Ministry of Health
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

ClinicalTrials.gov processed this record on October 01, 2014