A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement
NCT ID: NCT01369511
Last Updated: 2018-06-06
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
400 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-07-31
Study Completion Date
2014-02-28
Brief Summary
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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).
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Detailed Description
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Conditions
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Muscular Atrophy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Placebo
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered subcutaneously
35 mg LY2495655
LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Group Type
EXPERIMENTAL
LY2495655
Intervention Type
DRUG
Administered subcutaneously
105 mg LY2495655
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Group Type
EXPERIMENTAL
LY2495655
Intervention Type
DRUG
Administered subcutaneously
315 mg LY2495655
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Group Type
EXPERIMENTAL
LY2495655
Intervention Type
DRUG
Administered subcutaneously
Interventions
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LY2495655
Administered subcutaneously
Intervention Type
DRUG
Placebo
Administered subcutaneously
Intervention Type
DRUG
Eligibility Criteria
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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.
* 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
* 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.
* 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.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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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
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Tucson, Arizona, United States
Site Status
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Laguna Hills, California, United States
Site Status
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Lakewood, Colorado, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Pinellas Park, Florida, United States
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Tampa, Florida, United States
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Gainesville, Georgia, United States
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Boston, Massachusetts, United States
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Great Falls, Montana, United States
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Wilmington, North Carolina, United States
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Altoona, Pennsylvania, United States
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State College, Pennsylvania, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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Vienna, , Austria
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Wiener Neustadt, , Austria
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Genk, , Belgium
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Merksem, , Belgium
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Newmarket, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, , Canada
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Ballerup Municipality, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Kuopio, , Finland
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Oulu, , Finland
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Cahors, , France
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Montauban, , France
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Fukuoka, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
Site Status
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Nagano, , Japan
Site Status
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Osaka, , Japan
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Tokyo, , Japan
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Wakayama, , Japan
Site Status
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Alzira, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Granada, , Spain
Site Status
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Madrid, , Spain
Site Status
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Stockholm, , Sweden
Site Status
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Umeå, , Sweden
Site Status
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Uppsala, , Sweden
Site Status
Countries
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United States
Austria
Belgium
Canada
Denmark
Estonia
Finland
France
Japan
Spain
Sweden
References
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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.
Reference Type
DERIVED
Other Identifiers
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I1Q-MC-JDDE
Identifier Type: OTHER
Identifier Source: secondary_id
11671
Identifier Type: -
Identifier Source: org_study_id
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A Biomarker Study of ATH434 in Participants With MSA
NCT05864365
COMPLETED
PHASE2
A Study of ATL1102 or Placebo in Participants With Non-ambulatory Duchenne Muscular Dystrophy
NCT05938023
TERMINATED
PHASE2
Investigating Loss of Neuromuscular Junction Transmission Fidelity in Older Adults
NCT04904926
COMPLETED
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patients
NCT05517603
COMPLETED
PHASE1/PHASE2
A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy
NCT05337553
ACTIVE_NOT_RECRUITING
PHASE3
Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)
NCT01027884
COMPLETED
PHASE3
A Study of TAS-205 for Duchenne Muscular Dystrophy
NCT02246478
COMPLETED
PHASE1
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
NCT01309061
COMPLETED
NA
A Study of AMC6156 in People With Sarcopenia
NCT07072195
RECRUITING
PHASE2
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
NCT05693142
RECRUITING
PHASE2/PHASE3