CClinicalTrials.gg
CompletedNCT01369511Updated Jun 6, 2018Results posted

A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement

A Phase 2 interventional study of LY2495655 and Placebo in Muscular Atrophy, sponsored by Eli Lilly and Company. Completed at 45 sites in 11 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older participants undergoing elective total hip arthroplasty (eTHA).

02

Conditions studied

  • Muscular Atrophy

Keywords

  • Disuse Atrophy
  • Muscle
  • Strength
  • Arthroplasty
  • Hip
  • Joint Replacement
03

In context

Muscular Atrophy

494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's enrollment of 400 is above the median of 33 across 335 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males with a female partner of childbearing potential should use contraception during the treatment period of the trial and up to 15 weeks after the last dose of investigational product.
  • Females should be of non-child bearing potential.
  • Elective total hip arthroplasty (eTHA) is scheduled.
  • Have a body mass index of \<40 kilograms per square meter (kg/m\^2) and a weight \<136.4 kilograms (kg).
  • Can climb at least 6 stairs with or without holding the handrail (but without human assistance), according to the participant at screening.
  • Can stand up from a chair and walk more than 10 meters without human assistance.
  • Takes at least 12 seconds to perform the Timed Up and Go (TUG) test at screening.

Exclusion criteria

Exclusion Criteria:

  • Another inpatient surgical procedure is planned in the 6 months following randomization.
  • Lower extremity amputation.
  • Lower-limb fracture within 6 months prior to screening or any major lower-limb surgery within 3 months prior to randomization.
  • Simultaneous bilateral eTHA.
  • The planned surgical procedure will preclude weight bearing for at least 4 weeks postoperatively (for instance, the planned procedure will involve extensive bone grafting). "Partial weight-bearing" and "weight-bearing as tolerated" are acceptable, but "non weight-bearing," "touch weight-bearing," or "feather weight-bearing" are exclusive.
  • Underlying muscle disease (for example, polymyositis or muscular dystrophy) or a history of muscle disease other than age-associated muscle waste or disuse atrophy.
  • Recent neurologic injury (\<6 months prior to randomization) such as stroke or spinal cord injury, or unstable neurologic disorders that are likely to confound physical performance tests during the course of the study (such as unstable Parkinson disease or hemiplegia).
  • History of positive testing for human immunodeficiency virus (HIV).
  • Current use or previous use of any drugs known to influence muscle mass or performance within 6 months prior to randomization (this includes anabolic steroids, replacement therapy for gonadal deficiency, anti-androgens, luteinizing hormone-releasing hormone [LHRH] agonist and antagonists, growth hormone, Insulin-Like Growth Factor 1 [IGF1], or creatinine supplements) or systemic corticosteroid use for at least 3 months (in the last year) prior to randomization at a daily dose greater than or equal to a 10 mg prednisone equivalent.
  • Severe Vitamin D deficiency defined as 25-hydroxy-vitamin D levels \<9.2 nanograms per milliliter (ng/mL) or \<23 nanomoles per milliliter (nmol/mL) at screening.
  • History of a malignant neoplasm in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Participants with carcinoma in situ of the uterine cervix treated definitively for more than 1 year prior to screening may enter the study.
  • History of any of the following conditions within 90 days of screening: unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention (such as, angioplasty or stent placement).
  • Any current supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per minute [bpm]) at rest despite medical or device therapy, any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30 seconds) despite medical or device therapy, or any history of resuscitated cardiac arrest or the presence of an automatic internal cardioverter-defibrillator.
  • Any history of congestive heart failure within 6 months of screening.
  • Systolic blood pressure >160 or \<90 millimeters of mercury (mmHg) or diastolic blood pressure >100 or \<50 mmHg at screening, or malignant hypertension.
  • An abnormality in the locally read 12-lead electrocardiogram (ECG) that in the opinion of the investigator increases the risk of participating in the study.
  • Have either or both of the following: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >2 times the upper limit of normal (ULN), or alkaline phosphatase >1.5 times ULN, or total bilirubin >1.5 times ULN.
  • Known history or presence of severe acute or chronic liver disease.
  • History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance \<30 milliliters per minute (mL/minute) at screening.
  • Current evidence or recent history of significant psychiatric disease such as dementia/Alzheimer's disease, schizophrenia, or bipolar disorder.
  • Are currently enrolled in, or discontinued within the last 30 days (or 5 half-lives whichever is longer) from a clinical trial involving an investigational drug or off-label use of a drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Regularly uses known drugs of abuse and/or shows positive findings on urinary drug screening (physician prescribed narcotics are allowed).
  • Have a positive fecal occult blood (FOB) test at screening or cannot provide a stool sample for FOB testing prior to randomization.
  • Have uncontrolled diabetes mellitus.
  • Have had ocular trauma, ophthalmologic surgery, or eye laser treatment within 6 months prior to randomization.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
400 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Drug: Placebo

  • Experimental
    35 mg LY2495655

    LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Drug: LY2495655

  • Experimental
    105 mg LY2495655

    LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Drug: LY2495655

  • Experimental
    315 mg LY2495655

    LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Drug: LY2495655

Interventions

  • DrugLY2495655

    Administered subcutaneously

  • DrugPlacebo

    Administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12

    The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.

    Time frame: Baseline, 12 Weeks

Secondary outcomes

  1. Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16

    The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis.

    Time frame: Baseline, 4 Weeks, 8 Weeks, and 16 Weeks

07

Results

Posted Jun 6, 2018

Participant flow

Participant flow — Overall Study
MilestonePlacebo35 mg LY2495655105 mg LY2495655315 mg LY2495655
Started9810498100
Received at least 1 dose of study drug9810398100
Completed85918789
Not completed13131111
Withdrew: Adverse event1150
Withdrew: Entry criteria not met2001
Withdrew: Lost to follow-up0112
Withdrew: Protocol violation0102
Withdrew: Physician decision3400
Withdrew: Sponsor decision2010
Withdrew: Withdrawal by subject5646

Outcome measures

PrimaryChange From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12

The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.

Time frame:
Baseline, 12 Weeks
Reported as:
Least squares mean · percentage change in aLBM (3 limbs)
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12
percentage change in aLBM (3 limbs)Placebo35 mg LY2495655105 mg LY2495655315 mg LY2495655
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 120.297 ± 0.4920.741 ± 0.5001.018 ± 0.4711.357 ± 0.494
Statistical analysis
  • Placebo vs 35 mg LY2495655 · Mixed Models Analysis · p = 0.527 (p-values are from type 3 tests.)
  • Placebo vs 105 mg LY2495655 · Mixed Models Analysis · p = 0.291 (p-values are from type 3 tests.)
  • Placebo vs 315 mg LY2495655 · Mixed Models Analysis · p = 0.129 (p-values are from type 3 tests.)
SecondaryChange From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16

The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis.

Time frame:
Baseline, 4 Weeks, 8 Weeks, and 16 Weeks
Reported as:
Least squares mean · percentage change in aLBM (3 limbs)
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16
percentage change in aLBM (3 limbs)Placebo35 mg LY2495655105 mg LY2495655315 mg LY2495655
Week 4NA ± NANA ± NANA ± NANA ± NA
Week 8-0.900 ± 0.485-0.680 ± 0.4980.340 ± 0.4660.585 ± 0.488
Week 16-0.102 ± 0.4940.606 ± 0.5022.058 ± 0.4671.784 ± 0.494
Statistical analysis
  • Placebo vs 35 mg LY2495655 · Mixed Models Analysis · p = 0.751 (p-values are from type 3 tests.)
  • Placebo vs 105 mg LY2495655 · Mixed Models Analysis · p = 0.066 (p-values are from type 3 tests.)
  • Placebo vs 315 mg LY2495655 · Mixed Models Analysis · p = 0.031 (p-values are from type 3 tests.)
  • Placebo vs 35 mg LY2495655 · Mixed Models Analysis · p = 0.315 (p-values are from type 3 tests.)
  • Placebo vs 105 mg LY2495655 · Mixed Models Analysis · p = 0.002 (p-values are from type 3 tests.)
  • Placebo vs 315 mg LY2495655 · Mixed Models Analysis · p = 0.007 (p-values are from type 3 tests.)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—14/98 (14.3%)72/98 (73.5%)
35 mg LY2495655—8/104 (7.7%)76/104 (73.1%)
105 mg LY2495655—16/98 (16.3%)66/98 (67.3%)
315 mg LY2495655—3/100 (3%)68/100 (68%)
Most frequent serious events
Showing 10 of 43
Most frequent serious events
EventPlacebo35 mg LY2495655105 mg LY2495655315 mg LY2495655
OsteoarthritisMusculoskeletal and connective tissue disorders3/981/1041/980/100
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/980/1041/470/100
Postoperative wound infectionInfections and infestations0/980/1042/982/100
FallInjury, poisoning and procedural complications2/980/1040/980/100
Joint dislocationInjury, poisoning and procedural complications2/980/1040/980/100
AnaemiaBlood and lymphatic system disorders0/980/1041/980/100
Haemorrhagic anaemiaBlood and lymphatic system disorders0/980/1041/980/100
Sick sinus syndromeCardiac disorders1/980/1040/980/100
TachycardiaCardiac disorders0/980/1041/980/100
Gastrooesophageal reflux diseaseGastrointestinal disorders0/980/1041/980/100
Most frequent other events
Showing 10 of 27
Most frequent other events
EventPlacebo35 mg LY2495655105 mg LY2495655315 mg LY2495655
ArthralgiaMusculoskeletal and connective tissue disorders11/9822/10411/9814/100
NauseaGastrointestinal disorders12/9820/10416/9821/100
PyrexiaGeneral disorders11/9818/10413/9814/100
VomitingGastrointestinal disorders9/9816/1049/9812/100
ConstipationGastrointestinal disorders8/9814/1047/989/100
Injection site painGeneral disorders3/986/10413/9812/100
DizzinessNervous system disorders13/989/1046/989/100
Back painMusculoskeletal and connective tissue disorders3/989/10412/982/100
HypotensionVascular disorders9/989/10410/9812/100
AnaemiaBlood and lymphatic system disorders4/988/1047/9811/100

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(years)Placebo35 mg LY2495655105 mg LY2495666315 mg LY2495655Total
Mean69.38 ± 8.9068.66 ± 8.0967.85 ± 8.1468.71 ± 7.9568.65 ± 8.26
Sex: Female, Male
Sex: Female, Male(Participants)Placebo35 mg LY2495655105 mg LY2495666315 mg LY2495655Total
Female59705154234
Male39344746166
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo35 mg LY2495655105 mg LY2495666315 mg LY2495655Total
Hispanic or Latino11002
Not Hispanic or Latino52515655214
Unknown or Not Reported45524245184
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo35 mg LY2495655105 mg LY2495666315 mg LY2495655Total
American Indian or Alaska Native00000
Asian121491146
Native Hawaiian or Other Pacific Islander00000
Black or African American11215
White85898788349
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Placebo35 mg LY2495655105 mg LY2495666315 mg LY2495655Total
France03014
United States27292631113
Estonia115131241
Canada1620191974
Finland747422
Belgium447520
Spain777526
Austria453517
Denmark11116634
Japan111491145
Sweden02114
Body Mass Index (BMI)
Body Mass Index (BMI)(kilograms per meter squared (kg/m^2))Placebo35 mg LY2495655105 mg LY2495666315 mg LY2495655Total
Mean28.58 ± 4.8228.78 ± 4.9428.14 ± 4.3128.51 ± 4.4728.51 ± 4.63
08

Study locations

45 sites
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    Tucson, Arizona 85712, United States
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    Laguna Hills, California 92653, United States
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    Lakewood, Colorado 80227, United States
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    Fort Lauderdale, Florida 33316, United States
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    Jacksonville, Florida 32209, United States
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    Orlando, Florida 32804, United States
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    Pinellas Park, Florida 33781, United States
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    Tampa, Florida 33637, United States
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    Gainesville, Georgia 30501, United States
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    Boston, Massachusetts 02120, United States
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    Great Falls, Montana 59405, United States
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    Wilmington, North Carolina 28401, United States
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    Altoona, Pennsylvania 16602, United States
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    State College, Pennsylvania 16801, United States
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    Memphis, Tennessee 38163, United States
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    Houston, Texas 77043, United States
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    Vienna, 1130, Austria
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    Wiener Neustadt, 2700, Austria
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    Genk, 3600, Belgium
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    Merksem, 2170, Belgium
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    Newmarket, Ontario L3Y 2P9, Canada
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    Waterloo, Ontario N2J 1C4, Canada
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    Montreal, Quebec H2E 1S6, Canada
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    Quebec, G1R 2J6, Canada
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    Ballerup, 2750, Denmark
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    Tallinn, 10611, Estonia
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    Tartu, 50410, Estonia
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    Kuopio, 70211, Finland
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    Oulu, 90210, Finland
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    Cahors Cedex 9, 46005, France
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    Montauban Cedex, 82013, France
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    Fukuoka, 814-0180, Japan
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    Hokkaido, 085-0024, Japan
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    Hyogo, 660-8511, Japan
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    Nagano, 390-8601, Japan
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    Osaka, 573-1191, Japan
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    Tokyo, 158-0095, Japan
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    Wakayama, 640-8158, Japan
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    Alcira, 46600, Spain
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    Barcelona, 08025, Spain
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    Granada, 18012, Spain
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    Madrid, 28034, Spain
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    Stockholm, SE-118 83, 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.
    Umea, 90185, 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.
    Uppsala, 75185, Sweden
09

References and documents

Publications

  • Woodhouse L, Gandhi R, Warden SJ, Poiraudeau S, Myers SL, Benson CT, Hu L, Ahmad QI, Linnemeier P, Gomez EV, Benichou O; STUDY INVESTIGATORS. A Phase 2 Randomized Study Investigating the Efficacy and Safety of Myostatin Antibody LY2495655 versus Placebo in Patients Undergoing Elective Total Hip Arthroplasty. J Frailty Aging. 2016;5(1):62-70. doi: 10.14283/jfa.2016.81. PubMed 26980371 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01369511
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 9, 2011
Start date
Jul 2011
Primary completion
Feb 2014
Completion
Feb 2014
Results posted
Jun 6, 2018
Last update
Jun 6, 2018

Study contacts

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
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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