Clinical trial NCT01963598: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcopenia
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2013-10-16
Enrollment: 253
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent change in total lean body mass
timeFrame: day 1 to day 85
Secondary outcomes:
measure: TEAEs
timeFrame: day 1 to day 141
measure: Change in appendicular lean mass
timeFrame: day 1 to day 141
measure: Change in maximal leg press strength (1-RM)
timeFrame: day 1 to day 141
measure: Change in maximal chest press strength (1-RM)
timeFrame: day 1 to day 141
measure: Change in 4M gait speed
timeFrame: day 1 to day 141
measure: Change in SPPB subscores
timeFrame: day 1 to day 141
measure: Change in distance walked in the 6MWT
timeFrame: day 1 to day 141
measure: Change in regional and total fat mass by DEXA
timeFrame: day 1 to day 141
measure: Change in hand grip strength by handheld dynamometer
timeFrame: day 1 to day 141
measure: Change in unloaded and loaded stair climb power
timeFrame: day 1 to day 141
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: El Cajon
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: College Park
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: High Point
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Athens
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
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
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: