A Study in Older Participants Who Have Fallen and Have Muscle Weakness
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01604408
First received: May 21, 2012
Last updated: April 4, 2013
Last verified: April 2013
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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 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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
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 | |
| 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 |
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 4, 2013 |
| 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 May 16, 2013