Dose Range Finding Study in Sarcopenia

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 14-006590
    NCT ID: NCT02333331
    Sponsor Protocol Number: CBYM338E2202

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Low muscle mass as confirmed by DXA;
  • Low gait speed;
  • Weigh at least 40kg;
  • 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);
  • Any underlying muscle disease including active myopathy or muscular dytrophy;
  • Confirmed diagnosis of heart failure classified as New York Heart Association Class III and IV (e.g. cardiomyopathy) or hypertrophic cardiomyopathy;
  • Type I diabetes or uncontrolled Type 2 diabetes;
  • Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Nathan LeBrasseur, M.S., Ph.D.

Closed for enrollment

Additional contact information

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Phone: 800-664-4542 (toll-free)

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