Sarcopenia Clinical Trial NCT02333331
Novartis Pharma AG is sponsoring a clinical research trial "InvestiGAIT" for adults 70 years and older with sarcopenia. Sarcopenia is a condition associated with the aging process. The main symptoms or signs that you have this condition include: a greater than normal loss of muscle mass and strength, which results in a slower walking pace, makes climbing stairs and getting out of a chair more difficult and affects balance and the overall ability to perform tasks of daily living.
The purpose of the study InvestiGAIT is to see if the drug called bimagrumab (BYM338) is safe and beneficial in people with sarcopenia, in particular those who have difficulty walking or climbing stairs. Bimagrumab is a type of drug called a monoclonal antibody. The study is being conducted by physicians in ten countries around the world.
If you are eligible and agree to participate in this study, you will be treated with either bimagrumab (the study drug) or a placebo (a dummy drug with no medicine inside, like a sugar pill) over 21 weeks.
To see if you may be eligible, click here for a pre-screener.
Patients who participate in this trial must meet the following requirements:
- Man or woman 70 years of age or older
- Have difficulty walking, rising from a chair or climbing stairs
- Weigh at least 77 pounds or 35.0 kg and not obese
- Live within 2 hours drive of the study site (further distances should be discussed with the study site)
- Have not participated in other studies where a trial medication was received in the last 30 days
Patients who enroll in this trial:
- Will attend study visits, weekly for the first month and then monthly, for a minimum of 28 weeks
- Will not be charged to participate
- May withdraw from the trial at any time.
To learn more about sarcopenia, referred to as age-related frailty, click here.
Additional study physicians may be listed in the future. You can also share this information via the links at the top of the page.