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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
Time frame: Baseline, week 25
Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
Time frame: Baseline, week 25
Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person's usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).
Time frame: baseline, week 25
Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m\^2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
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Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Cypress, California, United States
Novartis Investigative Site
La Jolla, California, United States
Novartis Investigative Site
Farmington, Connecticut, United States
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami Lakes, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Gainesville, Georgia, United States
Novartis Investigative Site
Boston, Massachusetts, United States
...and 48 more locations
Time frame: baseline, week 25
Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
Change from Baseline to Week 25 on Total lean body mass and appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(LBM at Visit - LBM at Baseline) / LBM at Baseline\] \* 100.
Time frame: baseline, week 25