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

February 29, 2016 updated by: Regeneron Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
day 1 to day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
day 1 to day 141
Change in appendicular lean mass
Time Frame: day 1 to day 141
Changes from baseline (day 1) in appendicular lean mass by DEXA
day 1 to day 141
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)
day 1 to day 141
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)
day 1 to day 141
Change in 4M gait speed
Time Frame: day 1 to day 141
Change from baseline in 4-meter (4M) gait speed
day 1 to day 141
Change in SPPB subscores
Time Frame: day 1 to day 141
Change from baseline in SPPB (Short Physical Performance Battery) subscores
day 1 to day 141
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)
day 1 to day 141
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
day 1 to day 141
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
day 1 to day 141
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
day 1 to day 141

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R1033-SRC-1239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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