Dose Range Finding Study of Bimagrumab in Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: bimagrumab; placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed

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.
    

Eligibility criteria:

        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 (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).