E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Muscle wasting which includes shrinking of the muscle and weakness. This can occur when a muscle is no longer as active as usual. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013521 |
E.1.2 | Term | Disuse muscle atrophy |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study, in older patients who have fallen recently and have muscle weakness, is to test the hypothesis that LY2495655 will increase appendicular lean body mass( aLBM) versus placebo 24 weeks after starting treatment. |
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E.2.2 | Secondary objectives of the trial |
To assess the effects of LY2495655 versus placebo on the following measures of physical function over the course of the study:
• Stair climbing (StC)
• Repeated chair stands (RCS)
• Usual gait speed (uGS) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males or females aged 75 years or older.
- Sustained at least 1 fall within 1 calendar year prior to the screening visit.
- Requires greater than or equals to12 seconds to perform a repeated chair stands test or is unable to complete this test at the screening visit.
- Hand grip strength is less than or equal to 37 kg for men or less than or equal to 21 kg for women at the screening visit.
- Can stand up from a chair and walk greater than or equal to10 meters without human assistance at the screening visit.
- Able to climb at least 1 step on a staircase without human assistance according to the patient at the screening visit. |
|
E.4 | Principal exclusion criteria |
- Have a major active vestibular vertigo or a major neurologic disorder severely reducing their mobility.
- Are unable to safely perform the protocol-specified tests of physical performance due to a major visual impairment.
- Severe vitamin D deficiency before the randomization visit.
- Current use or previous use of any drugs known to influence muscle mass or performance.
- Have had a recent neurologic injury.
- Have a history or presence of unstable cardiovascular comorbidities.
- Have a positive fecal occult blood (FOB) test at screening or the patient cannot provide a stool sample for FOB testing prior to randomization. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in appendicular lean body mass. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 weeks after the first injection |
|
E.5.2 | Secondary end point(s) |
Stair climbing
Repeated chair stands
Usual gait speed |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12, 24 and 36 weeks (after 1st injection) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
France |
Germany |
Sweden |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |