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

• ClinicalTrials.gov Identifier: NCT01910220
• Recruitment Status: Completed
• First Posted: July 29, 2013
• Last Update Posted: November 10, 2014
• Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Tracking Information

• First Submitted Date: July 25, 2013
• First Posted Date: July 29, 2013
• Last Update Posted Date: November 10, 2014
• Study Start Date: August 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2013)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 25, 2013)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
• Official Title: Not Provided
• Brief Summary: This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Healthy Volunteers

Intervention

• Drug: REGN1033 (SAR391786)
• Other: placebo

Study Arms

• Placebo Comparator: Group 1
  placebo
  Intervention: Other: placebo
• Experimental: Group 2
  REGN1033 (SAR391786)
  Intervention: Drug: REGN1033 (SAR391786)
• Placebo Comparator: Group 3
  placebo + exercise regimen
  Intervention: Other: placebo
• Experimental: Group 4
  REGN1033 (SAR391786) + exercise regimen
  Intervention: Drug: REGN1033 (SAR391786)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 9, 2014): 125
• Original Estimated Enrollment (submitted: July 25, 2013): 120
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01910220
• Other Study ID Numbers: R1033-HV-1223
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Regeneron Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Regeneron Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Sanofi

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

• PRS Account: Regeneron Pharmaceuticals
• Verification Date: November 2014