Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2011

Geographic Reach

10 countries

43 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

June 7, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed

22 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed

4.3 years until next milestone

Results Posted

Study results publicly available

June 6, 2018

Completed

Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

June 7, 2011

Results QC Date

March 24, 2018

Last Update Submit

May 4, 2018

Conditions

Muscular Atrophy

Keywords

Disuse AtrophyMuscleStrengthArthroplastyHipJoint Replacement

Outcome Measures

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.
Baseline, 12 Weeks

Secondary Outcomes (1)

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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

35 mg LY2495655

EXPERIMENTAL

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

Drug: LY2495655

105 mg LY2495655

EXPERIMENTAL

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

Drug: LY2495655

315 mg LY2495655

EXPERIMENTAL

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

Drug: LY2495655

Interventions

LY2495655DRUG

Administered subcutaneously

105 mg LY2495655315 mg LY249565535 mg LY2495655

PlaceboDRUG

Administered subcutaneously

Placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (45)

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.

Tucson, Arizona, 85712, United States

Location

Laguna Hills, California, 92653, United States

Location

Lakewood, Colorado, 80227, United States

Location

Fort Lauderdale, Florida, 33316, United States

Location

Jacksonville, Florida, 32209, United States

Location

Orlando, Florida, 32804, United States

Location

Pinellas Park, Florida, 33781, United States

Location

Tampa, Florida, 33637, United States

Location

Gainesville, Georgia, 30501, United States

Location

Boston, Massachusetts, 02120, United States

Location

Great Falls, Montana, 59405, United States

Location

Wilmington, North Carolina, 28401, United States

Location

Altoona, Pennsylvania, 16602, United States

Location

State College, Pennsylvania, 16801, United States

Location

Memphis, Tennessee, 38163, United States

Location

Houston, Texas, 77043, United States

Location

Vienna, 1130, Austria

Location

Wiener Neustadt, 2700, Austria

Location

Genk, 3600, Belgium

Location

Merksem, 2170, Belgium

Location

Newmarket, Ontario, L3Y 2P9, Canada

Location

Waterloo, Ontario, N2J 1C4, Canada

Location

Montreal, Quebec, H2E 1S6, Canada

Location

Québec, G1R 2J6, Canada

Location

Ballerup Municipality, 2750, Denmark

Location

Tallinn, 10611, Estonia

Location

Tartu, 50410, Estonia

Location

Kuopio, 70211, Finland

Location

Oulu, 90210, Finland

Location

Cahors, 46005, France

Location

Montauban, 82013, France

Location

Fukuoka, 814-0180, Japan

Location

Hokkaido, 085-0024, Japan

Location

Hyōgo, 660-8511, Japan

Location

Nagano, 390-8601, Japan

Location

Osaka, 573-1191, Japan

Location

Tokyo, 158-0095, Japan

Location

Wakayama, 640-8158, Japan

Location

Alzira, 46600, Spain

Location

Barcelona, 08025, Spain

Location

Granada, 18012, Spain

Location

Madrid, 28034, Spain

Location

Stockholm, SE-118 83, Sweden

Location

Umeå, 90185, Sweden

Location

Uppsala, 75185, Sweden

Location

Related Publications (1)

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.
PMID: 26980371DERIVED

MeSH Terms

Conditions

Muscular AtrophyMuscular Disorders, Atrophic

Interventions

landogrozumab

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 9, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 6, 2018

Results First Posted

June 6, 2018

Record last verified: 2018-05

Locations

DK(1)BE(2)FI(2)CA(4)SE(3)US(16)ES(4)FR(2)AU(2)JP(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Placebo

35 mg LY2495655

105 mg LY2495655

315 mg LY2495655

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (45)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations