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
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.
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.
Single dose cohort
Multiple dose cohorts
All subjects
Exclusion Criteria:
Single dose cohort
Multiple dose cohort
All subjects
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
Drug: LY2495655
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Drug: LY2495655
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Drug: LY2495655
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Drug: LY2495655
Single Placebo dose administered intravenously (IV)
Drug: Placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Drug: Placebo
administered intravenously or subcutaneously
administered intravenously or subcutaneously
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)
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
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
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
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
| Milestone | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo |
|---|---|---|---|---|---|---|
| Started | 6 | 9 | 10 | 10 | 2 | 10 |
| Received at least 1 dose of study drug | 6 | 9 | 10 | 10 | 2 | 10 |
| Completed | 6 | 9 | 9 | 9 | 2 | 9 |
| Not completed | 0 | 0 | 1 | 1 | 0 | 1 |
| Withdrew: Sponsor decision | 0 | 0 | 1 | 1 | 0 | 1 |
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.
| Participants | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Effects | 0 | 0 | 7 | 4 | 0 | 2 |
| picomoles per milliliter (pmol/mL) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 |
|---|---|---|---|---|
| Day 1 | 192 ± 7 | 8.11 ± 41 | 102 ± 80 | 303 ± 42 |
| Day 57 | — | 23.8 ± 36 | 304 ± 32 | 1060 ± 24 |
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.
| nanomoles*hour per milliliter(nmol*h/mL) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 |
|---|---|---|---|---|
| Day 1 | 50.5 ± 11 | 2.32 ± 34 | 24.0 ± 59 | 79.8 ± 40 |
| Day 57 | — | 6.82 ± 39 | 88.7 ± 32 | 319 ± 23 |
| hours (h) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 |
|---|---|---|---|---|
| Day 1 | 0.58 (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) |
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.
| percentage change | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo |
|---|---|---|---|---|---|---|
| Day 22 | 0.30 ± 2.33 | 0.40 ± 1.40 | 1.51 ± 2.48 | 1.80 ± 1.46 | NA ± NA | -1.15 ± 1.81 |
| Day 71 | — | 1.33 ± 2.47 | 2.88 ± 2.39 | 3.48 ± 2.84 | — | -1.22 ± 2.97 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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%) |
| Event | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo |
|---|---|---|---|---|---|---|
| Injection site haematomaGeneral disorders | 0/6 | 2/9 | 6/10 | 3/10 | 0/2 | 0/10 |
| Vessel puncture site haematomaGeneral disorders | 3/6 | 5/9 | 4/10 | 3/10 | 0/2 | 3/10 |
| Upper respiratory tract infectionInfections and infestations | 0/6 | 0/9 | 0/10 | 0/10 | 1/2 | 0/10 |
| Viral upper respiratory tract infectionInfections and infestations | 0/6 | 1/9 | 1/10 | 0/10 | 1/2 | 2/10 |
| Injection site erythemaGeneral disorders | 0/6 | 0/9 | 3/10 | 2/10 | 0/2 | 0/10 |
| Injection site painGeneral disorders | 0/6 | 0/9 | 3/10 | 0/10 | 0/2 | 0/10 |
| Injection site reactionGeneral disorders | 0/6 | 0/9 | 3/10 | 2/10 | 0/2 | 0/10 |
| HeadacheNervous system disorders | 0/6 | 1/9 | 3/10 | 1/10 | 0/2 | 0/10 |
| ContusionInjury, poisoning and procedural complications | 0/6 | 2/9 | 0/10 | 0/10 | 0/2 | 1/10 |
| ExcoriationInjury, poisoning and procedural complications | 0/6 | 2/9 | 1/10 | 0/10 | 0/2 | 1/10 |
All randomized participants
| Age, Continuous(years) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 49.7 ± 4.2 | 64.6 ± 7.2 | 61.2 ± 6.9 | 60.3 ± 3.3 | 48.0 ± 11.3 | 65.0 ± 9.2 | 60.4 ± 8.5 |
| Sex: Female, Male(Participants) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 2 | 3 | 4 | 3 | 1 | 4 | 17 |
| Male | 4 | 6 | 6 | 7 | 1 | 6 | 30 |
| Race/Ethnicity, Customized(Participants) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| Asian/Japanese | 6 | 9 | 10 | 10 | 2 | 10 | 47 |
| Region of Enrollment(Participants) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| United States | 6 | 9 | 10 | 10 | 2 | 10 | 47 |
| Weight(kilograms (kg)) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 66.48 ± 8.55 | 62.04 ± 7.31 | 63.29 ± 12.56 | 64.05 ± 9.08 | 57.15 ± 12.66 | 62.90 ± 12.36 | 63.28 ± 10.05 |
| Height(centimeters (cm)) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 167.83 ± 6.81 | 163.57 ± 4.97 | 162.01 ± 8.11 | 162.70 ± 6.20 | 165.65 ± 15.06 | 164.52 ± 6.57 | 163.89 ± 6.82 |
| International Physical Activity Questionnaire (IPAQ)(MET-minutes per week) | Single IV Dose 70 mg LY2495655 | Multiple SC Dose 17.5 mg LY2495655 | Multiple SC Dose 140 mg LY2495655 | Multiple SC Dose 420 mg LY2495655 | Single IV Dose Placebo | Multiple SC Dose Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 1829.25 ± 1619.29 | 278.11 ± 341.65 | 130.80 ± 214.24 | 331.50 ± 301.53 | NA ± NA | 108.40 ± 198.18 | 436.10 ± 803.71 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eli Lilly and Company