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
1 other identifier
interventional
253
4 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2013
CompletedFirst Posted
Study publicly available on registry
October 16, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 28, 2016
February 1, 2016
1.2 years
October 11, 2013
February 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
TEAEs
day 1 to day 141
Change in appendicular lean mass
day 1 to day 141
Change in maximal leg press strength (1-RM)
day 1 to day 141
Change in maximal chest press strength (1-RM)
day 1 to day 141
Change in 4M gait speed
day 1 to day 141
- +5 more secondary outcomes
Study Arms (4)
Group 1
EXPERIMENTALDosing regimen 1
Group 2
EXPERIMENTALDosing regimen 2
Group 3
EXPERIMENTALDosing regimen 3
Group 4
EXPERIMENTALDosing regimen 4
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (43)
Unknown Facility
Anniston, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
El Cajon, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
South Miami, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
College Park, Maryland, United States
Unknown Facility
Elkridge, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Edina, Minnesota, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Athens, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Spartanburg, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
West Jordan, Utah, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Limoges, France
Unknown Facility
Montpellier, France
Unknown Facility
Saint-Etienne, France
Unknown Facility
Toulouse, France
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Leeuwarden, Netherlands
Unknown Facility
Noord-Brabant, Netherlands
Unknown Facility
Albacete, Spain
Unknown Facility
L'Hospitalet de Llobregat, Spain
Unknown Facility
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2013
First Posted
October 16, 2013
Study Start
November 1, 2013
Primary Completion
January 1, 2015
Study Completion
February 1, 2015
Last Updated
March 28, 2016
Record last verified: 2016-02