Dose Range Finding Study of Bimagrumab in Sarcopenia



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:70 - Any
Updated:12/8/2018
Start Date:December 9, 2014
End Date:June 28, 2018

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A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)

The purpose of this study is 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 will generate data on the safety,
tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.


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;

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).
We found this trial at
18
sites
Rochester, Minnesota 55905
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Rochester, MN
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Adelaide, South Australia
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Adelaide,
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Boston, Massachusetts 02118
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Boston, MA
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Columbus, Ohio 43205
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Columbus, OH
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Cypress, California 90630
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Cypress, CA
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Farmington, Connecticut 06030
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Farmington, CT
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Gainesville, Florida 32608
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Gainesville, FL
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Gainesville, Georgia 30501
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Gainesville, GA
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High Point, North Carolina 27262
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High Point, NC
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La Jolla, California 92037
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La Jolla, CA
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Little Rock, Arkansas 72204
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Little Rock, AR
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Madison, Wisconsin 53705
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Madison, WI
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Mesquite, Texas 75150
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Mesquite, TX
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Miami, Florida 33136
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Miami, FL
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Miami Lakes, Florida 33014
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Miami Lakes, FL
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Orlando, Florida 32806
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Orlando, FL
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Antonio, TX
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Spartanburg, South Carolina 29302
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Spartanburg, SC
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