MUSCLE Study

 

Study Type
Healthy Aging
Study Purpose
The purpose of the study is to evaluate the effects of an investigational drug, REGN1033, on body composition, muscle strength and function.
About the Study

Sarcopenia refers to muscle wasting associated with aging. Its causes may include disuse, chronic disease, a change in food and nutritional intake, and changes in the way a person’s hormones work. People with sarcopenia often experience a loss of independence, a greater risk of disability and difficulty performing their daily activities. The main treatment of sarcopenia is resistance or strength training that increases muscle strength; no drug treatment has been as effective as exercise (resistance training).

The study drug, REGN1033 is being studied for the treatment of sarcopenia. REGN1033 is an antibody directed against myostatin. Myostatin is a protein produced by muscles which can prevent muscles from getting larger and can lead to muscle wasting in some individuals. An antibody is a protein produced by the body that is used by the immune system to identify and neutralize foreign objects such as bacteria and viruses.

Study Design

Number of visits:

  • 3 Screening visits
  • 7 Clinic visits
  • 1 Follow-up visit

Study procedures:

  • Physical exam, height, weight, vitals
  • Electrocardiogram (ECG) and Echocardiogram (Echo)
  • Blood draw and urine test
  • DXA scans
  • Exercise testing
  • Questionnaires
  • Accelerometry: A small device called an Actigraph will be worn twice for a period of 2 weeks at a time to measure participants' activity level at home
  • Self-guided physical activity/walking program: All participants will be instructed to begin Step 1 of "The First Step to Active Health" program to increase aerobic exercise. Participants will do this on their own at home during the 12 weeks of study treatment. Participants will be instructed to walk 5 to 10 minutes on most days of the week progressing to 30 minutes on most days of the week.

Subject groups:

  • 300 mg injection of REGN1033 every 2 weeks, for a total of 6 doses
  • 300 mg injection of REGN1033 every 4 weeks, for a total of 3 doses
  • 100 mg injection of REGN1033 every 4 weeks, for a total of 3 doses
  • Placebo injection every 2 weeks for a total of 6 doses

Eligible participants in this study will be randomized to 1 of 4 treatment groups (3 study drug groups of different doses and 1 placebo group) and will receive 3 abdominal injections every 2 weeks for a period of 12 weeks. Throughout the study participants will complete strength and function exercise tests, body composition scans, and various safety measures. Participants will also be instructed to begin a simple physical activity/walking program on their own at home during the course of the study. All study-related procedures will be provided at no cost to the participant.

Study Qualifications
Study Duration
6 Months
Compensation
Earn up to $500 for participation.
Study Contact
If you are interested in volunteering for the MUSCLE study, click here to screen online, call 225-763-3000 or email clinicaltrials@pbrc.edu.

If you think you may be eligible, please click the button below to screen online.



Please do not fill out this questionnaire for anyone other than yourself unless you are their legal guardian.
If you know someone who may be interested please direct them to the site or have them call us directly at 225-763-3000.

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