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

Phase 2

Completed

• Conditions: Sarcopenia
• Interventions: Drug: REGN1033 (SAR391786); Drug: placebo

• Registration Number: NCT01963598
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Start: 2013-11
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-29
• Disposition First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Disposition First Posted: 2016-03-28
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal)
2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions
3. Ability to follow a walking program
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. Able to understand and complete study-related questionnaires

Exclusion Criteria

1. Hospitalization or immobilization with a duration of >48 hours within the month prior to screening
2. Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
3. 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
4. Chronic medications introduced within 2 weeks prior to screening
5. Respiratory disease that requires oxygen treatment
6. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
7. Neurological conditions that are causing impaired muscle function or mobility
8. Certain cardiovascular conditions
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percent change in total lean body mass	day 1 to day 85	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).

Secondary Outcome Measures

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