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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01910220
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : November 10, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: REGN1033 (SAR391786) Other: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group 1
placebo
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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)

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


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910220


Locations
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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
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01910220    
Other Study ID Numbers: R1033-HV-1223
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014