Muscular AtrophyPhase 2NCT01369511

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

A Phase 2 study testing LY2495655 in people with Muscular Atrophy, run by Eli Lilly and Company at 45 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Muscular Atrophy
What is being tested?: LY2495655
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 400 participants
Where: 45 sitesin 11 countries
Study dates: Jul 2011to Feb 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

45 sites in 11 countries.

Country

City, postcode or hospital

45 sites in 11 countries

United States16 sites

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.
Altoona, Pennsylvania, 16602
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Boston, Massachusetts, 02120
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Fort Lauderdale, Florida, 33316
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Gainesville, Georgia, 30501
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Great Falls, Montana, 59405
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Houston, Texas, 77043
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Jacksonville, Florida, 32209
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Laguna Hills, California, 92653
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Lakewood, Colorado, 80227
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Memphis, Tennessee, 38163
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Orlando, Florida, 32804
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Pinellas Park, Florida, 33781
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State College, Pennsylvania, 16801
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Tampa, Florida, 33637
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Tucson, Arizona, 85712
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Wilmington, North Carolina, 28401

Other trials in United States

Japan7 sites

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Fukuoka, 814-0180
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Hokkaido, 085-0024
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Hyōgo, 660-8511
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Nagano, 390-8601
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Osaka, 573-1191
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Tokyo, 158-0095
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Wakayama, 640-8158

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Canada4 sites

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Montreal, Quebec, H2E 1S6
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Newmarket, Ontario, L3Y 2P9
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Québec, G1R 2J6
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Waterloo, Ontario, N2J 1C4

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Spain4 sites

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Alzira, 46600
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Barcelona, 08025
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Granada, 18012
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Madrid, 28034

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Sweden3 sites

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Stockholm, SE-118 83
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Umeå, 90185
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Uppsala, 75185

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Austria2 sites

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Vienna, 1130
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Wiener Neustadt, 2700

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Belgium2 sites

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Genk, 3600
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Merksem, 2170

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Estonia2 sites

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Tallinn, 10611
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Tartu, 50410

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Finland2 sites

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Kuopio, 70211
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Oulu, 90210

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France2 sites

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Cahors, 46005
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Montauban, 82013

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Denmark1 site

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Ballerup Municipality, 2750

Other trials in Denmark

About this study

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

Conditions: Muscular Atrophy
Being tested: LY2495655, Placebo
Keywords: Disuse Atrophy, Muscle, Strength, Arthroplasty, Hip, Joint Replacement
Medical subject headings: Muscular Atrophy, Muscular Disorders, Atrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2495655Drug
Administered subcutaneously
PlaceboDrug
Administered subcutaneously

Study groups in NCT01369511
Study group	Role	What they receive
Placebo	Placebo comparator	Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) Receives: Drug: Placebo
35 mg LY2495655	Experimental	LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) Receives: Drug: LY2495655
105 mg LY2495655	Experimental	LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) Receives: Drug: LY2495655
315 mg LY2495655	Experimental	LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) Receives: Drug: LY2495655

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, 4 Weeks, 8 Weeks, and 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2014

First posted9 Jun 2011 (estimated)
Study startJul 2011
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Muscular AtrophyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369511
Sponsor's protocol ID: 11671
Other IDs: I1Q-MC-JDDE
Status last verified: May 2018
First submitted: 7 Jun 2011
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01369511
Acronym / sponsor ID: 11671
Conditions: Muscular Atrophy
Keywords: Disuse Atrophy, Muscle, Strength, Arthroplasty, Hip, Joint Replacement
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 9 Jun 2011 (estimated)
Results: Posted 6 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboAdministered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
35 mg LY2495655	Experimental	Drug: LY2495655LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
105 mg LY2495655	Experimental	Drug: LY2495655LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
315 mg LY2495655	Experimental	Drug: LY2495655LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2495655Administered subcutaneously	Drug	105 mg LY2495655, 315 mg LY2495655, 35 mg LY2495655
PlaceboAdministered subcutaneously	Drug	Placebo

Primary outcome

Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12
Time frame: Baseline, 12 Weeks
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 6 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	98	85
35 mg LY2495655	104	91
105 mg LY2495655	98	87
315 mg LY2495655	100	89

Primary outcome: Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12

Time frame: Baseline, 12 Weeks. Least squares mean (Standard Error). Unit: percentage change in aLBM (3 limbs)

Measure	Placebo n = 70	35 mg LY2495655 n = 68	105 mg LY2495655 n = 76	315 mg LY2495655 n = 69
Value	0.297 (0.492)	0.741 (0.500)	1.018 (0.471)	1.357 (0.494)

Placebo vs 35 mg LY2495655: p = 0.527, Mixed Models Analysis
Placebo vs 105 mg LY2495655: p = 0.291, Mixed Models Analysis
Placebo vs 315 mg LY2495655: p = 0.129, Mixed Models Analysis

Population analysed: Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	14 of 98 (14.3%)	72 of 98 (73.5%)	Not reported
35 mg LY2495655	8 of 104 (7.7%)	76 of 104 (73.1%)	Not reported
105 mg LY2495655	16 of 98 (16.3%)	66 of 98 (67.3%)	Not reported
315 mg LY2495655	3 of 100 (3%)	68 of 100 (68%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26980371Woodhouse 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

45 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2495655 in people with Muscular Atrophy, run by Eli Lilly and Company at 45 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Japan, Canada, Spain, Sweden and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12 (time frame: Baseline, 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369511, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.