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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT01963598
• Date of registration: 11/10/2013
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
• Scientific 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
• Date of first enrolment: November 2013
• Target sample size: 253
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01963598
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Germany, Netherlands, Spain, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcopenia

Intervention(s)

Drug: placebo

Drug: REGN1033 (SAR391786)

Primary Outcome(s)

Percent change in total lean body mass [Time Frame: day 1 to day 85]

Secondary Outcome(s)

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

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

Change in 4M gait speed [Time Frame: day 1 to day 141]

Change in SPPB subscores [Time Frame: day 1 to day 141]

Change in maximal leg press strength (1-RM) [Time Frame: day 1 to day 141]

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

Change in distance walked in the 6MWT [Time Frame: day 1 to day 141]

TEAEs [Time Frame: day 1 to day 141]

Change in appendicular lean mass [Time Frame: day 1 to day 141]

Change in maximal chest press strength (1-RM) [Time Frame: day 1 to day 141]

Secondary ID(s)

R1033-SRC-1239

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi