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

Primary Purpose

Muscle Weakness

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2495655

Placebo

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY2495655

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)

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

Change From Baseline in Stair Climbing (StC) Time

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.

Change From Baseline in Repeated Chair Stands (RCS) Time

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.

Change From Baseline in Usual Gait Speed (uGS) at 4 Meters

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.

Full Information

NCT ID

NCT01604408

First Posted

May 21, 2012

Last Updated

March 24, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01604408

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

LY2495655 is an investigational drug being tested for muscle wasting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Weakness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY2495655

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

LY2495655

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)

Description

Time Frame

Baseline to 24 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Stair Climbing (StC) Time

Description

Time Frame

Baseline to 24 weeks

Title

Change From Baseline in Repeated Chair Stands (RCS) Time

Description

Time Frame

Baseline to 24 weeks

Title

Change From Baseline in Usual Gait Speed (uGS) at 4 Meters

Description

Time Frame

Baseline to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

1405

Country

Argentina

Facility Name

City

Hornsby

State/Province

New South Wales

ZIP/Postal Code

2077

Country

Australia

Facility Name

City

Kingswood

State/Province

New South Wales

ZIP/Postal Code

2747

Country

Australia

Facility Name

City

Daw Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

TSA 60033

Country

France

Facility Name

City

Köln

ZIP/Postal Code

50668

Country

Germany

Facility Name

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

City

Huddinge

ZIP/Postal Code

14186

Country

Sweden

Facility Name

City

Mölndal

ZIP/Postal Code

43180

Country

Sweden

Facility Name

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

26516121

Citation

Becker C, Lord SR, Studenski SA, Warden SJ, Fielding RA, Recknor CP, Hochberg MC, Ferrari SL, Blain H, Binder EF, Rolland Y, Poiraudeau S, Benson CT, Myers SL, Hu L, Ahmad QI, Pacuch KR, Gomez EV, Benichou O; STEADY Group. Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):948-57. doi: 10.1016/S2213-8587(15)00298-3. Epub 2015 Oct 27.

Results Reference

derived

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

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