Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01963598
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : March 28, 2016
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sarcopenia Drug: REGN1033 (SAR391786) Drug: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

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



Primary Outcome Measures :
  1. Percent change in total lean body mass [ Time Frame: 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 :
  1. TEAEs [ Time Frame: day 1 to day 141 ]
    TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141).

  2. Change in appendicular lean mass [ Time Frame: day 1 to day 141 ]
    Changes from baseline (day 1) in appendicular lean mass by DEXA

  3. Change in maximal leg press strength (1-RM) [ Time Frame: day 1 to day 141 ]
    Change from baseline in maximal leg press strength (1-repetition max)

  4. Change in maximal chest press strength (1-RM) [ Time Frame: day 1 to day 141 ]
    Change from baseline in maximal chest press strength (1-repetition max)

  5. Change in 4M gait speed [ Time Frame: day 1 to day 141 ]
    Change from baseline in 4-meter (4M) gait speed

  6. Change in SPPB subscores [ Time Frame: day 1 to day 141 ]
    Change from baseline in SPPB (Short Physical Performance Battery) subscores

  7. Change in distance walked in the 6MWT [ Time Frame: day 1 to day 141 ]
    Change from baseline in distance walked in the 6MWT (6-Minute Walk Test)

  8. Change in regional and total fat mass by DEXA [ Time Frame: day 1 to day 141 ]
    Change from baseline in regional and total fat mass by DEXA

  9. Change in hand grip strength by handheld dynamometer [ Time Frame: day 1 to day 141 ]
    Change from baseline in hand grip strength by handheld dynamometer

  10. Change in unloaded and loaded stair climb power [ Time Frame: day 1 to day 141 ]
    Change from baseline in unloaded and loaded stair climb power



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963598


Locations
Layout table for location information
United States, Alabama
Anniston, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
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
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Maryland
College Park, Maryland, United States
Elkridge, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, North Carolina
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Athens, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, South Carolina
Spartanburg, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Richmond, Virginia, United States
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
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01963598    
Other Study ID Numbers: R1033-SRC-1239
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms