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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Drug: placebo; Drug: REGN1033 (SAR391786)

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Limoges, France
  • Montpellier Cedex 5, France
  • Saint-Etienne Cedex 2, France
  • Toulouse, France
• Netherlands
  • Amsterdam, Netherlands
  • Leeuwarden, Netherlands
  • Noord-Brabant, Netherlands
• Spain
  • Albacete, Spain
  • L'Hospitalet de Llobregat, Spain
  • Madrid, Spain
• United States
  • Alabama
    • Anniston, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • El Cajon, California, United States
    • Garden Grove, California, United States
    • Laguna Hills, California, United States
    • San Francisco, California, United States
    • Walnut Creek, California, United States
  • Colorado
    • Aurora, Colorado, United States
  • Florida
    • Gainesville, Florida, United States
    • Jacksonville, Florida, United States
    • Jupiter, Florida, United States
    • Orlando, Florida, United States
    • South Miami, Florida, United States
  • Illinois
    • Chicago, Illinois, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
  • Maryland
    • College Park, Maryland, United States
    • Elkridge, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Minnesota
    • Edina, Minnesota, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • North Carolina
    • High Point, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Athens, Ohio, United States
    • Columbus, Ohio, United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
  • South Carolina
    • Spartanburg, South Carolina, United States
  • Texas
    • Dallas, Texas, United States
    • Plano, Texas, United States
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
    • West Jordan, Utah, United States
  • Virginia
    • Richmond, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Dosing regimen 1	Drug: REGN1033 (SAR391786)
Experimental: Group 2; Dosing regimen 2	Drug: placebo; Drug: REGN1033 (SAR391786)
Experimental: Group 3; Dosing regimen 3	Drug: placebo; Drug: REGN1033 (SAR391786)
Experimental: Group 4; Dosing regimen 4	Drug: placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): March 28, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: R1033-SRC-1239