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Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: July 25, 2013
Last updated: November 7, 2014
Last verified: November 2014
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.

Condition Intervention Phase
Healthy Volunteers Drug: REGN1033 (SAR391786) Other: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percent change in total lean mass [ Time Frame: At week 12 ]
    The primary endpoint is percent change in total lean mass at week 12 (day 85)

Secondary Outcome Measures:
  • Number of TEAEs [ Time Frame: day 1 to day 141 ]
    Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study)

  • Appendicular lean mass by DXA [ Time Frame: At week 12 ]
    Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12

Enrollment: 125
Study Start Date: August 2013
Study Completion Date: October 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
Other: placebo
Experimental: Group 2
REGN1033 (SAR391786)
Drug: REGN1033 (SAR391786)
Placebo Comparator: Group 3
placebo + exercise regimen
Other: placebo
Experimental: Group 4
REGN1033 (SAR391786) + exercise regimen
Drug: REGN1033 (SAR391786)


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
  2. Low activity lifestyle
  3. Diet and exercise adherence

Exclusion Criteria:

  1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
  2. Participation in any clinical trial within 6 months prior to screening.
  3. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.
  4. Limb amputation (except for toes) and/or any fracture within 6 months.

The above information 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01910220

United States, Florida
Gainesville, Florida, United States
Orlando, Florida, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Ohio
Athens, Ohio, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01910220     History of Changes
Other Study ID Numbers: R1033-HV-1223
Study First Received: July 25, 2013
Last Updated: November 7, 2014 processed this record on August 18, 2017