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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: placebo; Drug: REGN1033 (SAR391786)

• Registration Number: NCT01910220
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Study Start: 2013-08
• Primary Completion: 2014-06
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	placebo	placebo + exercise regimen
Group 4	REGN1033 (SAR391786)	REGN1033 (SAR391786) + exercise regimen
Group 2	REGN1033 (SAR391786)	REGN1033 (SAR391786)
Group 1	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Percent change in total lean mass	At week 12	The primary endpoint is percent change in total lean mass at week 12 (day 85)

Secondary Outcome Measures

Name	Time	Method
Number of TEAEs	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	At week 12	Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12