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

This study is currently recruiting participants.
Verified February 2014 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01910220
First received: July 25, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12


Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01910220

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

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

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01910220     History of Changes
Other Study ID Numbers: R1033-HV-1223
Study First Received: July 25, 2013
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 20, 2014