Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Sarcopenia

In brief

This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.

Key facts

Study ID

NCT01963598

Run by

Regeneron Pharmaceuticals

People needed

253

Starts

2013-11-01

Expected to finish

2015-02-01

Last updated by the study team

2016-03-28

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 70 years and older (all women participating in the study must be postmenopausal)
• Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions
• Ability to follow a walking program
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Able to understand and complete study-related questionnaires

You may not qualify if…

• Hospitalization or immobilization with a duration of >48 hours within the month prior to screening
• Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
• Participate in resistance training more than 3 times per week and regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
• Chronic medications introduced within 2 weeks prior to screening
• Respiratory disease that requires oxygen treatment
• Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
• Neurological conditions that are causing impaired muscle function or mobility
• Certain cardiovascular conditions
• Uncontrolled diabetes
• The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — El Cajon, California, United States
• Study site — Garden Grove, California, United States
• Study site — Laguna Hills, California, United States
• Study site — San Francisco, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — College Park, Maryland, United States
• Study site — Elkridge, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Edina, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — High Point, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Athens, Ohio, United States
• Study site — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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