A Phase 2 interventional study of LY2495655 and Placebo in Muscular Atrophy, sponsored by Eli Lilly and Company. Completed at 45 sites in 11 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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).
494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.
This study's enrollment of 400 is above the median of 33 across 335 interventional studies indexed under Muscular Atrophy.
Browse Muscular Atrophy studies →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.
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Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: Placebo
LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: LY2495655
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: LY2495655
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
Drug: LY2495655
Administered subcutaneously
Administered subcutaneously
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.
Time frame: Baseline, 12 Weeks
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.
Time frame: Baseline, 4 Weeks, 8 Weeks, and 16 Weeks
| Milestone | Placebo | 35 mg LY2495655 | 105 mg LY2495655 | 315 mg LY2495655 |
|---|---|---|---|---|
| Started | 98 | 104 | 98 | 100 |
| Received at least 1 dose of study drug | 98 | 103 | 98 | 100 |
| Completed | 85 | 91 | 87 | 89 |
| Not completed | 13 | 13 | 11 | 11 |
| Withdrew: Adverse event | 1 | 1 | 5 | 0 |
| Withdrew: Entry criteria not met | 2 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 2 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 2 |
| Withdrew: Physician decision | 3 | 4 | 0 | 0 |
| Withdrew: Sponsor decision | 2 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 6 | 4 | 6 |
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.
| percentage change in aLBM (3 limbs) | Placebo | 35 mg LY2495655 | 105 mg LY2495655 | 315 mg LY2495655 |
|---|---|---|---|---|
| Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12 | 0.297 ± 0.492 | 0.741 ± 0.500 | 1.018 ± 0.471 | 1.357 ± 0.494 |
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.
| percentage change in aLBM (3 limbs) | Placebo | 35 mg LY2495655 | 105 mg LY2495655 | 315 mg LY2495655 |
|---|---|---|---|---|
| Week 4 | NA ± NA | NA ± NA | NA ± NA | NA ± NA |
| Week 8 | -0.900 ± 0.485 | -0.680 ± 0.498 | 0.340 ± 0.466 | 0.585 ± 0.488 |
| Week 16 | -0.102 ± 0.494 | 0.606 ± 0.502 | 2.058 ± 0.467 | 1.784 ± 0.494 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 14/98 (14.3%) | 72/98 (73.5%) |
| 35 mg LY2495655 | — | 8/104 (7.7%) | 76/104 (73.1%) |
| 105 mg LY2495655 | — | 16/98 (16.3%) | 66/98 (67.3%) |
| 315 mg LY2495655 | — | 3/100 (3%) | 68/100 (68%) |
| Event | Placebo | 35 mg LY2495655 | 105 mg LY2495655 | 315 mg LY2495655 |
|---|---|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/98 | 1/104 | 1/98 | 0/100 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/98 | 0/104 | 1/47 | 0/100 |
| Postoperative wound infectionInfections and infestations | 0/98 | 0/104 | 2/98 | 2/100 |
| FallInjury, poisoning and procedural complications | 2/98 | 0/104 | 0/98 | 0/100 |
| Joint dislocationInjury, poisoning and procedural complications | 2/98 | 0/104 | 0/98 | 0/100 |
| AnaemiaBlood and lymphatic system disorders | 0/98 | 0/104 | 1/98 | 0/100 |
| Haemorrhagic anaemiaBlood and lymphatic system disorders | 0/98 | 0/104 | 1/98 | 0/100 |
| Sick sinus syndromeCardiac disorders | 1/98 | 0/104 | 0/98 | 0/100 |
| TachycardiaCardiac disorders | 0/98 | 0/104 | 1/98 | 0/100 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/98 | 0/104 | 1/98 | 0/100 |
| Event | Placebo | 35 mg LY2495655 | 105 mg LY2495655 | 315 mg LY2495655 |
|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 11/98 | 22/104 | 11/98 | 14/100 |
| NauseaGastrointestinal disorders | 12/98 | 20/104 | 16/98 | 21/100 |
| PyrexiaGeneral disorders | 11/98 | 18/104 | 13/98 | 14/100 |
| VomitingGastrointestinal disorders | 9/98 | 16/104 | 9/98 | 12/100 |
| ConstipationGastrointestinal disorders | 8/98 | 14/104 | 7/98 | 9/100 |
| Injection site painGeneral disorders | 3/98 | 6/104 | 13/98 | 12/100 |
| DizzinessNervous system disorders | 13/98 | 9/104 | 6/98 | 9/100 |
| Back painMusculoskeletal and connective tissue disorders | 3/98 | 9/104 | 12/98 | 2/100 |
| HypotensionVascular disorders | 9/98 | 9/104 | 10/98 | 12/100 |
| AnaemiaBlood and lymphatic system disorders | 4/98 | 8/104 | 7/98 | 11/100 |
All randomized participants
| Age, Continuous(years) | Placebo | 35 mg LY2495655 | 105 mg LY2495666 | 315 mg LY2495655 | Total |
|---|---|---|---|---|---|
| Mean | 69.38 ± 8.90 | 68.66 ± 8.09 | 67.85 ± 8.14 | 68.71 ± 7.95 | 68.65 ± 8.26 |
| Sex: Female, Male(Participants) | Placebo | 35 mg LY2495655 | 105 mg LY2495666 | 315 mg LY2495655 | Total |
|---|---|---|---|---|---|
| Female | 59 | 70 | 51 | 54 | 234 |
| Male | 39 | 34 | 47 | 46 | 166 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 35 mg LY2495655 | 105 mg LY2495666 | 315 mg LY2495655 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 0 | 2 |
| Not Hispanic or Latino | 52 | 51 | 56 | 55 | 214 |
| Unknown or Not Reported | 45 | 52 | 42 | 45 | 184 |
| Race (NIH/OMB)(Participants) | Placebo | 35 mg LY2495655 | 105 mg LY2495666 | 315 mg LY2495655 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 12 | 14 | 9 | 11 | 46 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 | 1 | 5 |
| White | 85 | 89 | 87 | 88 | 349 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | 35 mg LY2495655 | 105 mg LY2495666 | 315 mg LY2495655 | Total |
|---|---|---|---|---|---|
| France | 0 | 3 | 0 | 1 | 4 |
| United States | 27 | 29 | 26 | 31 | 113 |
| Estonia | 11 | 5 | 13 | 12 | 41 |
| Canada | 16 | 20 | 19 | 19 | 74 |
| Finland | 7 | 4 | 7 | 4 | 22 |
| Belgium | 4 | 4 | 7 | 5 | 20 |
| Spain | 7 | 7 | 7 | 5 | 26 |
| Austria | 4 | 5 | 3 | 5 | 17 |
| Denmark | 11 | 11 | 6 | 6 | 34 |
| Japan | 11 | 14 | 9 | 11 | 45 |
| Sweden | 0 | 2 | 1 | 1 | 4 |
| Body Mass Index (BMI)(kilograms per meter squared (kg/m^2)) | Placebo | 35 mg LY2495655 | 105 mg LY2495666 | 315 mg LY2495655 | Total |
|---|---|---|---|---|---|
| Mean | 28.58 ± 4.82 | 28.78 ± 4.94 | 28.14 ± 4.31 | 28.51 ± 4.47 | 28.51 ± 4.63 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company