Dose Range Finding Study of Bimagrumab in Sarcopenia
Phase 2
Completed
- Conditions
- Sarcopenia
- Registration Number
- jRCT2080222848
- Lead Sponsor
- Novartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 280
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
- 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) < 30 mL/min]
- History of confirmed chronic obstructive pulmonary disease with a severity grade > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Randomized, double-blind, placebo controlled, multi-center, parallel group study
- Primary Outcome Measures
Name Time Method Short Physical Performance Battery baseline, week 25 Change from baseline to week 25
- Secondary Outcome Measures
Name Time Method Total lean body mass and appendicular skeletal muscle index measured by DXA baseline, week 25 Change from baseline to Week 25
safety baseline, weeks 1, 5, 9, 13, 17, 21 and 25 Safety and tolerability as assessed by various measures such as adverse events
6-minute walk test Baseline, week 25 Change from baseline to week 25
Gait speed baseline, week 25 Change from baseline to Week 25
Trial Locations
- Locations (1)
Japan/Asia except Japan/North America/Europe/Oceania
Location not specified
Japan/Asia except Japan/North America/Europe/Oceania