Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia

Conditions
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Sarcopenia

Intervention / Treatment
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* Drug: REGN1033 (SAR391786)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 70 years and older (all women participating in the study must be postmenopausal) Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions Ability to follow a walking program Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Able to understand and complete study-related questionnaires Exclusion Criteria: Hospitalization or immobilization with a duration of >48 hours within the month prior to screening Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months Participate in resistance training more than 3 times per week and regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity Chronic medications introduced within 2 weeks prior to screening Respiratory disease that requires oxygen treatment Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer) Neurological conditions that are causing impaired muscle function or mobility Certain cardiovascular conditions Uncontrolled diabetes The information listed above 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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Dosing regimen 1 | Drug: REGN1033 (SAR391786)<br> <br> |
| Experimental: Group 2<br>Dosing regimen 2 | Drug: REGN1033 (SAR391786)<br> <br> Drug: placebo<br> <br> |
| Experimental: Group 3<br>Dosing regimen 3 | Drug: REGN1033 (SAR391786)<br> <br> Drug: placebo<br> <br> |
| Experimental: Group 4<br>Dosing regimen 4 | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in total lean body mass | The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85). | day 1 to day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEAEs | TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141). | day 1 to day 141 | 
| Change in appendicular lean mass | Changes from baseline (day 1) in appendicular lean mass by DEXA | day 1 to day 141 | 
| Change in maximal leg press strength (1-RM) | Change from baseline in maximal leg press strength (1-repetition max) | day 1 to day 141 | 
| Change in maximal chest press strength (1-RM) | Change from baseline in maximal chest press strength (1-repetition max) | day 1 to day 141 | 
| Change in 4M gait speed | Change from baseline in 4-meter (4M) gait speed | day 1 to day 141 | 
| Change in SPPB subscores | Change from baseline in SPPB (Short Physical Performance Battery) subscores | day 1 to day 141 | 
| Change in distance walked in the 6MWT | Change from baseline in distance walked in the 6MWT (6-Minute Walk Test) | day 1 to day 141 | 
| Change in regional and total fat mass by DEXA | Change from baseline in regional and total fat mass by DEXA | day 1 to day 141 | 
| Change in hand grip strength by handheld dynamometer | Change from baseline in hand grip strength by handheld dynamometer | day 1 to day 141 | 
| Change in unloaded and loaded stair climb power | Change from baseline in unloaded and loaded stair climb power | day 1 to day 141 |