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

NCT ID: NCT01963598

Last Updated: 2016-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Dosing regimen 1

Group Type EXPERIMENTAL

REGN1033 (SAR391786)

Intervention Type DRUG

Group 2

Dosing regimen 2

Group Type EXPERIMENTAL

REGN1033 (SAR391786)

Intervention Type DRUG

placebo

Intervention Type DRUG

Group 3

Dosing regimen 3

Group Type EXPERIMENTAL

REGN1033 (SAR391786)

Intervention Type DRUG

placebo

Intervention Type DRUG

Group 4

Dosing regimen 4

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Interventions

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REGN1033 (SAR391786)

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Anniston, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

El Cajon, California, United States

Site Status

Garden Grove, California, United States

Site Status

Laguna Hills, California, United States

Site Status

San Francisco, California, United States

Site Status

Walnut Creek, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Gainesville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Jupiter, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

South Miami, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Baton Rouge, Louisiana, United States

Site Status

College Park, Maryland, United States

Site Status

Elkridge, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Edina, Minnesota, United States

Site Status

Omaha, Nebraska, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

High Point, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Athens, Ohio, United States

Site Status

Columbus, Ohio, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Spartanburg, South Carolina, United States

Site Status

Dallas, Texas, United States

Site Status

Plano, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

West Jordan, Utah, United States

Site Status

Richmond, Virginia, United States

Site Status

Limoges, , France

Site Status

Montpellier, , France

Site Status

Saint-Etienne, , France

Site Status

Toulouse, , France

Site Status

Amsterdam, , Netherlands

Site Status

Leeuwarden, , Netherlands

Site Status

Noord-Brabant, , Netherlands

Site Status

Albacete, , Spain

Site Status

L'Hospitalet de Llobregat, , Spain

Site Status

Madrid, , Spain

Site Status

Countries

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United States France Netherlands Spain

Other Identifiers

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R1033-SRC-1239

Identifier Type: -

Identifier Source: org_study_id

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