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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01604408
• Date of registration: 21/05/2012
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• 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
• Date of first enrolment: May 2012
• Target sample size: 201
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01604408
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, France, Germany, Sweden, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.



Age minimum: 75 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Muscle Weakness

Intervention(s)

Biological: LY2495655

Drug: Placebo

Primary Outcome(s)

Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM) [Time Frame: Baseline to 24 weeks]

Secondary Outcome(s)

Change From Baseline in Repeated Chair Stands (RCS) Time [Time Frame: Baseline to 24 weeks]

Change From Baseline in Usual Gait Speed (uGS) at 4 Meters [Time Frame: Baseline to 24 weeks]

Change From Baseline in Stair Climbing (StC) Time [Time Frame: Baseline to 24 weeks]

Secondary ID(s)

I1Q-MC-JDDJ

14499

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01604408