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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01369511
First received: June 7, 2011
Last updated: April 14, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Muscular Atrophy
Drug: LY2495655
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to 12 Week Endpoint in appendicular Lean Body Mass [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in appendicular Lean Body Mass [ Time Frame: Baseline, 4 Weeks, 8 Weeks, and 16 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 384
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: Placebo
Administered subcutaneously
Experimental: 35 mg LY2495655
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: LY2495655
Administered subcutaneously
Experimental: 105 mg LY2495666
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: LY2495655
Administered subcutaneously
Experimental: 315 mg LY2495655
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: LY2495655
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 kilogram per square meter (kg/ m²) and a weight <136.4 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
  • Take 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 10 milligram (mg) prednisone equivalent
  • Severe Vitamin D deficiency defined as 25-hydroxy-vitamin D levels <9.2 nanogram per milliliter (ng/mL) or <23 nanomole 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 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 (eg, 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, or 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 (mm Hg) or diastolic blood pressure >100 or <50 mm Hg 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) or 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 milliliter 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 the participant cannot provide a stool sample for FOB testing prior to randomization
  • Have uncontrolled diabetes mellitus
  • Have had ocular trauma, opthalmologic surgery, or eye laser treatment within 6 months prior to randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369511

  Show 45 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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 Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01369511     History of Changes
Other Study ID Numbers: 11671, I1Q-MC-JDDE
Study First Received: June 7, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Eli Lilly and Company:
Disuse Atrophy
Muscle
Strength
Arthroplasty
Hip
Joint Replacement

Additional relevant MeSH terms:
Muscular Atrophy
Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014