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OpenTrials
Completed

NCT Number: NCT01963598

Study of the Safety and Efficacy of REGN1033 (SAR391786) 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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Limoges, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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.

Treatment and study plan

REGN1033 (SAR391786)

Drug

Placebo

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. Change in appendicular lean mass

    Time frame: day 1 to day 141

    Changes from baseline (day 1) in appendicular lean mass by DEXA

  3. 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)

  4. 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)

  5. Change in 4M gait speed

    Time frame: day 1 to day 141

    Change from baseline in 4-meter (4M) gait speed

  6. Change in SPPB subscores

    Time frame: day 1 to day 141

    Change from baseline in SPPB (Short Physical Performance Battery) subscores

  7. 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)

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2013
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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