Sarcopenia MedDRA version: 9.1 Level: LLT Classification code 10063024 Term: Sarcopenia
Conditions
Interventions
Product Name: MK-0773
Product Code: MK-0773
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: MK-0773
Other descriptive name: MK-0773
Concentration unit: mg mill
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, renal impairment, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: 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. ;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), and Months 1, 3, and 6; the lean body mass (LBM) will be measured using DEXA at screening, Months 0, 3, and 6. The primary endpoints of interest will be the change from baseline in bilateral leg press and total lean body mass (LBM) at Month 6. | — |
Countries
Denmark, Finland, France, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed