Dose Range Finding Study of Bimagrumab in Sarcopenia (NCT02333331) | Clinical Trial Compass
CompletedPhase 2
Dose Range Finding Study of Bimagrumab in Sarcopenia
United States217 participantsStarted 2014-12-09
Plain-language summary
The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.
Who can participate
Age range70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Low muscle mass as confirmed by DXA;
* Low gait speed \<0.8 m/s
* SPPB score less than or equal to 9;
* Weigh at least 35 kg;
* Adequate dietary intake;
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…
What they're measuring
1
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25