CClinicalTrials.gg
CompletedNCT01341470Updated Jun 17, 2019Results posted

A Study of LY2495655 in Healthy Subjects

A Phase 1 interventional study of LY2495655 and Placebo in Healthy Volunteer, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 24 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
24 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.

02

Conditions studied

  • Healthy Volunteer
03

In context

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
24 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Single dose cohort

    • Overtly healthy males or females, as determined by medical history and physical examination
    • Between the ages of 24 and 50 years
  • Multiple dose cohorts

    • Sedentary males and females with stable medical problems, if any, that, in the investigator's opinion, will not place the subject at increased risk by participating in the study and will not interfere with interpretation of the data
    • Between the ages of 50 and 85 years
    • Score \<600 Metabolic Equivalent Tasks (METs) per week based on International Physical Activity Questionnaire (IPAQ)
  • All subjects

    • Male subjects: agree to use a reliable method of birth control
    • Female subjects: women not of child-bearing potential due to surgical sterilization (at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause
    • Up to third generation Japanese, that is defined as all of the subject's biological grandparents are of exclusive Japanese descent and have been born in Japan
    • Are ambulatory and able to perform a stair climb test
    • Have clinical laboratory tests within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
    • Have venous access sufficient to allow for blood sampling and/or administration of investigational product for intravenous administration

Exclusion criteria

Exclusion Criteria:

  • Single dose cohort

    • Intend to use over the counter or prescription medication within 14 days prior to dosing through 2 months after dosing except for thyroid replacement hormones or non-absorbed topical preparations per investigator instructions
    • Abnormal supine blood pressure defined as diastolic blood pressure > 90 millimeters of mercury (mmHg) and/or systolic blood pressure >140 mmHg
  • Multiple dose cohort

    • If taking medications, subjects who have not been stable for at least 3 months, or the time required to produce stable effects of the drug
    • Abnormal supine blood pressure defined as >100 mmHg and/or systolic blood pressure >160 mmHg
  • All subjects

    • Have known allergies to LY2495655, related compounds or any components of the formulation
    • Have a history or presence of cardiovascular, respiratory (including moderate to severe restrictive lung disease and obstructive disease, chronic bronchitis, and those with symptomatic asthma), hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of constituting a risk when taking the study medication or of interfering with the interpretation of data
    • Have a history of seizures or convulsions, excluding febrile convulsions in childhood
    • Subjects with underlying muscle disease or a history of muscle disease (for example, polymyositis or rhabdomyolysis)
    • Evidence or recent history of significant active psychiatric disease such as schizophrenia, depression, or bipolar disorder
    • Recent immobilization or major trauma to the legs within 6 months
    • Knee or hip replacement or lower extremity amputation
    • Participate in, or have participated within 3 months of study drug administration, a regular resistance training program or plan to participate in an exercise program during the study
    • Actively working in a physically demanding profession
    • Have contraindications for the Magnetic Resonance Imaging (MRI) scan
    • Tattoos on the right leg if the tattoos are at least 20 years old and may have iron-containing pigments
    • Electrocardiogram (ECG) considered outside the normal limits for the study population by the investigator and relevant for interpretation or indicating cardiac disease
    • Clinically significant abnormality in neurologic or neurocognitive examinations at screening
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Single IV dose LY2495655

    Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)

    Drug: LY2495655

  • Experimental
    Multiple SC dose 17.5 mg LY2495655

    17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)

    Drug: LY2495655

  • Experimental
    Multiple SC dose 140 mg LY2495655

    140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)

    Drug: LY2495655

  • Experimental
    Multiple SC dose 420 mg LY2495655

    420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)

    Drug: LY2495655

  • Placebo comparator
    Single IV dose placebo

    Single Placebo dose administered intravenously (IV)

    Drug: Placebo

  • Placebo comparator
    Multiple SC dose placebo

    Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)

    Drug: Placebo

Interventions

  • DrugLY2495655

    administered intravenously or subcutaneously

  • DrugPlacebo

    administered intravenously or subcutaneously

06

What researchers measure

Primary outcomes

  1. Number of Participants With Clinically Significant Effects

    Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.

    Time frame: Baseline to study completion (up to 135 days)

Secondary outcomes

  1. Pharmacokinetics, Maximum Concentration (Cmax)

    Time frame: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose

  2. Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)

    Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration.

    Time frame: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose

  3. Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)

    Time frame: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose

  4. Percentage Change in Thigh Muscle Volume

    Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)\*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment\*time interaction and a random effect of subject where baseline values were included as a covariate.

    Time frame: Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms

07

Results

Posted Jun 17, 2019

Participant flow

Participant flow — Overall Study
MilestoneSingle IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose Placebo
Started691010210
Received at least 1 dose of study drug691010210
Completed699929
Not completed001101
Withdrew: Sponsor decision001101

Outcome measures

PrimaryNumber of Participants With Clinically Significant Effects

Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.

Time frame:
Baseline to study completion (up to 135 days)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Effects
ParticipantsSingle IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose Placebo
Number of Participants With Clinically Significant Effects007402
SecondaryPharmacokinetics, Maximum Concentration (Cmax)
Time frame:
Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose
Reported as:
Geometric mean · picomoles per milliliter (pmol/mL)
Pharmacokinetics, Maximum Concentration (Cmax)
picomoles per milliliter (pmol/mL)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655
Day 1192 ± 78.11 ± 41102 ± 80303 ± 42
Day 57—23.8 ± 36304 ± 321060 ± 24
SecondaryPharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)

Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration.

Time frame:
Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose
Reported as:
Geometric mean · nanomoles*hour per milliliter(nmol*h/mL)
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)
nanomoles*hour per milliliter(nmol*h/mL)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655
Day 150.5 ± 112.32 ± 3424.0 ± 5979.8 ± 40
Day 57—6.82 ± 3988.7 ± 32319 ± 23
SecondaryPharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)
Time frame:
Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose
Reported as:
Median · hours (h)
Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)
hours (h)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655
Day 10.58 (0.50 to 2.50)168 (48 to 335)168 (96 to 264)167 (48 to 335)
Day 57—48.0 (24.0 to 168)96.0 (47.8 to 168)96.0 (48.0 to 168)
SecondaryPercentage Change in Thigh Muscle Volume

Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)\*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment\*time interaction and a random effect of subject where baseline values were included as a covariate.

Time frame:
Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms
Reported as:
Mean · percentage change
Percentage Change in Thigh Muscle Volume
percentage changeSingle IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose Placebo
Day 220.30 ± 2.330.40 ± 1.401.51 ± 2.481.80 ± 1.46NA ± NA-1.15 ± 1.81
Day 71—1.33 ± 2.472.88 ± 2.393.48 ± 2.84—-1.22 ± 2.97

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Single IV Dose 70 mg LY2495655—0/6 (0%)4/6 (66.7%)
Multiple SC Dose 17.5 mg LY2495655—0/9 (0%)9/9 (100%)
Multiple SC Dose 140 mg LY2495655—0/10 (0%)10/10 (100%)
Multiple SC Dose 420 mg LY2495655—0/10 (0%)10/10 (100%)
Single IV Dose Placebo—0/2 (0%)2/2 (100%)
Multiple SC Dose Placebo—0/10 (0%)7/10 (70%)
Most frequent other events
Showing 10 of 55
Most frequent other events
EventSingle IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose Placebo
Injection site haematomaGeneral disorders0/62/96/103/100/20/10
Vessel puncture site haematomaGeneral disorders3/65/94/103/100/23/10
Upper respiratory tract infectionInfections and infestations0/60/90/100/101/20/10
Viral upper respiratory tract infectionInfections and infestations0/61/91/100/101/22/10
Injection site erythemaGeneral disorders0/60/93/102/100/20/10
Injection site painGeneral disorders0/60/93/100/100/20/10
Injection site reactionGeneral disorders0/60/93/102/100/20/10
HeadacheNervous system disorders0/61/93/101/100/20/10
ContusionInjury, poisoning and procedural complications0/62/90/100/100/21/10
ExcoriationInjury, poisoning and procedural complications0/62/91/100/100/21/10

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(years)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
Mean49.7 ± 4.264.6 ± 7.261.2 ± 6.960.3 ± 3.348.0 ± 11.365.0 ± 9.260.4 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
Female23431417
Male46671630
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
Asian/Japanese69101021047
Region of Enrollment
Region of Enrollment(Participants)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
United States69101021047
Weight
Weight(kilograms (kg))Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
Mean66.48 ± 8.5562.04 ± 7.3163.29 ± 12.5664.05 ± 9.0857.15 ± 12.6662.90 ± 12.3663.28 ± 10.05
Height
Height(centimeters (cm))Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
Mean167.83 ± 6.81163.57 ± 4.97162.01 ± 8.11162.70 ± 6.20165.65 ± 15.06164.52 ± 6.57163.89 ± 6.82
International Physical Activity Questionnaire (IPAQ)
International Physical Activity Questionnaire (IPAQ)(MET-minutes per week)Single IV Dose 70 mg LY2495655Multiple SC Dose 17.5 mg LY2495655Multiple SC Dose 140 mg LY2495655Multiple SC Dose 420 mg LY2495655Single IV Dose PlaceboMultiple SC Dose PlaceboTotal
Mean1829.25 ± 1619.29278.11 ± 341.65130.80 ± 214.24331.50 ± 301.53NA ± NA108.40 ± 198.18436.10 ± 803.71
08

Study locations

1 site
  • 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.
    Honolulu, Hawaii 96814, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01341470
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 25, 2011
Start date
May 2011
Primary completion
May 2012
Completion
May 2012
Results posted
Jun 17, 2019
Last update
Jun 17, 2019

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
No
View the source record on ClinicalTrials.gov ↗

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