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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01604408




Registration number
NCT01604408
Ethics application status
Date submitted
21/05/2012
Date registered
23/05/2012
Date last updated
25/04/2018

Titles & IDs
Public title
A Study in Older Participants Who Have Fallen and Have Muscle Weakness
Scientific 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
Secondary ID [1] 0 0
I1Q-MC-JDDJ
Secondary ID [2] 0 0
14499
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Weakness 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - LY2495655
Treatment: Drugs - Placebo

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

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


Other interventions: LY2495655
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)
Timepoint [1] 0 0
Baseline to 24 weeks
Secondary outcome [1] 0 0
Change From Baseline in Stair Climbing (StC) Time
Timepoint [1] 0 0
Baseline to 24 weeks
Secondary outcome [2] 0 0
Change From Baseline in Repeated Chair Stands (RCS) Time
Timepoint [2] 0 0
Baseline to 24 weeks
Secondary outcome [3] 0 0
Change From Baseline in Usual Gait Speed (uGS) at 4 Meters
Timepoint [3] 0 0
Baseline to 24 weeks

Eligibility
Key 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.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
France
State/province [10] 0 0
Montpellier
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Pessac
Country [13] 0 0
France
State/province [13] 0 0
Pierre Benite
Country [14] 0 0
France
State/province [14] 0 0
Toulouse
Country [15] 0 0
Germany
State/province [15] 0 0
Köln
Country [16] 0 0
Germany
State/province [16] 0 0
Stuttgart
Country [17] 0 0
Sweden
State/province [17] 0 0
Huddinge
Country [18] 0 0
Sweden
State/province [18] 0 0
Mölndal
Country [19] 0 0
Sweden
State/province [19] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
LY2495655 is an investigational drug being tested for muscle wasting.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01604408
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01604408