Sarcopenia
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Low muscle mass as confirmed by DXA - Low gait speed - SPPB score less than or equal to 9 - Weigh at least 35 kg - Adequate dietary intake Other protocol-defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: - A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g., stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management) - Requires regular assistance from another person for general activities of daily living (e.g., bathing, dressing, toileting) - Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening - Any underlying muscle disease including active myopathy or muscular dytrophy - Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy) - Type I diabetes or uncontrolled Type 2 diabetes; - Chronic kidney disease [estimated glomerular filtration rate (GFR) 2 on the Medical Research Council Dyspnea Scale - Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/d prednisone equivalent - Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis) - Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g., angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening - Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix) - Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc) Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Short Physical Performance Battery (Time Frame: baseline, week 25) Change from baseline to week 25 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Safety and tolerability as assessed by various measures such as adverse events (Time Frame: baseline, weeks 1, 5, 9, 13, 17, 21 and 25) Assessed by various measures such as adverse events over 24 weeks efficacy 6-minute walk test (Time Frame: Baseline, week 25) Change from baseline to week 25 efficacy Gait speed (Time Frame: baseline, week 25) Change from baseline to Week 25 efficacy Total lean body mass and appendicular skeletal muscle index measured by DXA (Time Frame: baseline, week 25) Change from baseline to Week 25 | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed