E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063024 |
E.1.2 | Term | Sarcopenia |
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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 main objective of this Phase IIA POC study is to evaluate the efficacy, safety, and tolerability of MK-0773 in elderly sarcopenic women. 1) To assess the effect of 6 months of treatment with MK-0773 on muscle strength, as determined by bilateral leg press, relative to placebo. 2) To assess the effect of 6 months of treatment with MK-0773 on total lean body mass (LBM), as determined by DEXA, relative to placebo. 3) To assess the safety and tolerability of 6 months of treatment with MK-0773
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E.2.2 | Secondary objectives of the trial |
1) To assess the effect of 6 months of treatment with MK-0773 on muscle power, as determined by stair climbing power, relative to placebo. 2) To evaluate the effect of 6 months of treatment with MK-0773 on mediolateral body sway with eyes open, relative to placebo. 3) To evaluate the effect of 6 months of treatment with MK-0773 on the short physical performance battery (SPPB) tests and its component, gait speed. 4) To evaluate the effect of 6 month of treatment with MK-0773 on self reported physical function (AM-PAC). 5) To perform endpoint validation analysis on performance-based and self-reported physical performance measures to identify optimal functional endpoints for Phase IIb and Phase III studies.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is a woman 65 years of age on day of signing the informed consent. 2. Patient has an aLBM/Ht2, measured by DEXA, > 1 SD below the mean of a healthy young adult population (peak). 3. Patient has self-reported difficulty in climbing 10 steps or walking ¼ mile outside on level ground without resting.
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E.4 | Principal exclusion criteria |
1. Patient has performed any vigorous exercise (see below) in the 3 months prior to screening (Visit 1) or plans to substantially change the level of physical activity during the study. 2. Patient has untreated depression, psychiatric conditions, respiratory illness, cardiac abnormalities and/or neuromuscular diseases (Parkinson’s disease, amyotrophic lateral sclerosis, stroke affecting lower extremity function and muscular dystrophy). Patient has conditions that cause significant muscular or joint pain or significantly limit mobility including rheumatoid arthritis, polymyalgia rheumatica, polymyositis, and fibromyalgia. Note: Patients with conditions such as osteoarthritis can participate unless their pain limits them from performing study procedures. Patients with polymyalgia affecting only limited parts of the upper body (i.e., neck, shoulder) can participate in the study. 3. Patient has a history of any form of cancer, with the following exceptions: a. Adequately treated superficial basal or squamous cell carcinoma of the skin or cervical carcinoma in situ. b. Solid tumor definitively treated without any history of recurrence for at least 5 years prior to screening
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E.5 End points |
E.5.1 | Primary end point(s) |
This is a 6-month study. The muscle strength determined by bilateral leg press will be measured at screening, randomization (Month 0), Months 1, 3, and 6 and in case of discontinuation from the study; the lean body mass (LBM) will be measured using DEXA at screening, Months 0, 3, and 6 and in case of discontinuation from the study. The primary endpoints of interest will be the change from baseline in bilateral leg press and total lean body mass (LBM) at Month 6. |
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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 | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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An interim efficacy analysis will be conducted when 50% of expected completers (approximately 40 per treatment group) complete the 6 month study. The study will be stopped if the treatment effects on both LBM and leg press are negative relative to placebo (point estimates of differences between MK-0773 and placebo are less than 0. The variability of the primary endpoints will also be checked and the sample size may be increased to ensure the study has sufficient power.
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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 | 7 |
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 | 7 |