Trial · NCT01604408

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

NCT01604408, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study in Older Participants Who Have Fallen and Have Muscle Weakness. Trials, record NCT01604408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01604408

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study in Older Participants Who Have Fallen and Have Muscle Weakness
NCT number: NCT01604408
Status: Completed
Phases: Phase 2
Enrollment: 201 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Muscle Weakness
Interventions: LY2495655, Placebo
First posted: 2012-05-23
Last updated: 2018-04-25
Results first posted: 2018-04-25

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)	Baseline to 24 weeks	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	Change From Baseline in Stair Climbing (StC) Time	Baseline to 24 weeks	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.
Secondary	Change From Baseline in Repeated Chair Stands (RCS) Time	Baseline to 24 weeks	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.
Secondary	Change From Baseline in Usual Gait Speed (uGS) at 4 Meters	Baseline to 24 weeks	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)	Baseline to 24 weeks	All participants who received at least 1 dose of LY2495655 or placebo with evaluable aLBM data.	kilograms (kg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Stair Climbing (StC) Time	Baseline to 24 weeks	All participants who received at least 1 dose of LY2495655 or placebo with evaluable StC time data.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Repeated Chair Stands (RCS) Time	Baseline to 24 weeks	All participants who received at least 1 dose of LY2495655 or placebo with evaluable RCS time data.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Usual Gait Speed (uGS) at 4 Meters	Baseline to 24 weeks	All participants who received at least 1 dose of LY2495655 or placebo with evaluable uGS data.	meters per second (m/s)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)	LY2495655	0.303	Standard Error 0.085	kilograms (kg)
Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)	Placebo	-0.123	Standard Error 0.083	kilograms (kg)
Change From Baseline in Stair Climbing (StC) Time	LY2495655	-0.276	Standard Error 0.182	seconds
Change From Baseline in Stair Climbing (StC) Time	Placebo	0.184	Standard Error 0.178	seconds
Change From Baseline in Repeated Chair Stands (RCS) Time	LY2495655	-1.888	Standard Error 0.588	seconds
Change From Baseline in Repeated Chair Stands (RCS) Time	Placebo	0.826	Standard Error 0.551	seconds
Change From Baseline in Usual Gait Speed (uGS) at 4 Meters	LY2495655	0.030	Standard Error 0.017	meters per second (m/s)
Change From Baseline in Usual Gait Speed (uGS) at 4 Meters	Placebo	0.013	Standard Error 0.017	meters per second (m/s)

Source ClinicalTrials.gov

Participant flow44

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period 1	STARTED	LY2495655	102
Treatment Period 1	STARTED	Placebo	99
Treatment Period 1	Received at Least 1 Dose of Study Drug	LY2495655	102
Treatment Period 1	Received at Least 1 Dose of Study Drug	Placebo	99
Treatment Period 1	COMPLETED	LY2495655	102
Treatment Period 1	COMPLETED	Placebo	98
Treatment Period 1	NOT COMPLETED	LY2495655	0
Treatment Period 1	NOT COMPLETED	Placebo	1
Treatment Period 2	STARTED	LY2495655	102
Treatment Period 2	STARTED	Placebo	98

1 to 10 of 44Source ClinicalTrials.gov

See all 44 participant flow

Adverse events160

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	LY2495655	7	102	8
other	Constipation	Gastrointestinal disorders	Placebo	3	99	3
other	Diarrhoea	Gastrointestinal disorders	LY2495655	6	102	8
other	Diarrhoea	Gastrointestinal disorders	Placebo	7	99	8
other	Asthenia	General disorders	LY2495655	4	102	4
other	Asthenia	General disorders	Placebo	5	99	5
other	Fatigue	General disorders	LY2495655	12	102	14
other	Fatigue	General disorders	Placebo	3	99	3
other	Injection site bruising	General disorders	LY2495655	6	102	8
other	Injection site bruising	General disorders	Placebo	0	99	0

1 to 10 of 160Source ClinicalTrials.gov

See all 160 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LY2495655
Total, all-cause mortality	Placebo
Total, other adverse events	LY2495655	90	102
Total, other adverse events	Placebo	77	99
Total, serious adverse events	LY2495655	27	102
Total, serious adverse events	Placebo	18	99

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26516121	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
LY2495655 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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