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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
REGN1033 (SAR391786)
placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Dosing regimen 1

Dosing regimen 2

Dosing regimen 3

Dosing regimen 4

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2013
Last Updated
February 29, 2016
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01963598
Brief Title
Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Dosing regimen 1
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Dosing regimen 2
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Dosing regimen 3
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Dosing regimen 4
Intervention Type
Drug
Intervention Name(s)
REGN1033 (SAR391786)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Percent change in total lean body mass
Description
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).
Time Frame
day 1 to day 85
Secondary Outcome Measure Information:
Title
TEAEs
Description
TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141).
Time Frame
day 1 to day 141
Title
Change in appendicular lean mass
Description
Changes from baseline (day 1) in appendicular lean mass by DEXA
Time Frame
day 1 to day 141
Title
Change in maximal leg press strength (1-RM)
Description
Change from baseline in maximal leg press strength (1-repetition max)
Time Frame
day 1 to day 141
Title
Change in maximal chest press strength (1-RM)
Description
Change from baseline in maximal chest press strength (1-repetition max)
Time Frame
day 1 to day 141
Title
Change in 4M gait speed
Description
Change from baseline in 4-meter (4M) gait speed
Time Frame
day 1 to day 141
Title
Change in SPPB subscores
Description
Change from baseline in SPPB (Short Physical Performance Battery) subscores
Time Frame
day 1 to day 141
Title
Change in distance walked in the 6MWT
Description
Change from baseline in distance walked in the 6MWT (6-Minute Walk Test)
Time Frame
day 1 to day 141
Title
Change in regional and total fat mass by DEXA
Description
Change from baseline in regional and total fat mass by DEXA
Time Frame
day 1 to day 141
Title
Change in hand grip strength by handheld dynamometer
Description
Change from baseline in hand grip strength by handheld dynamometer
Time Frame
day 1 to day 141
Title
Change in unloaded and loaded stair climb power
Description
Change from baseline in unloaded and loaded stair climb power
Time Frame
day 1 to day 141

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Anniston
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
El Cajon
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
South Miami
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
College Park
State/Province
Maryland
Country
United States
City
Elkridge
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Athens
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Spartanburg
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
West Jordan
State/Province
Utah
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Limoges
Country
France
City
Montpellier Cedex 5
Country
France
City
Saint-Etienne Cedex 2
Country
France
City
Toulouse
Country
France
City
Amsterdam
Country
Netherlands
City
Leeuwarden
Country
Netherlands
City
Noord-Brabant
Country
Netherlands
City
Albacete
Country
Spain
City
L'Hospitalet de Llobregat
Country
Spain
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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