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SarcopeniaPhase 2NCT01963598

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

A Phase 2 study testing REGN1033 (SAR391786) in people with Sarcopenia, run by Regeneron Pharmaceuticals at 43 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Sarcopenia
What is being tested?
REGN1033 (SAR391786)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
253 participants
Where
43 sitesin 4 countries
Study dates
Nov 2013to Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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.

Trial locations and contacts

43 sites in 4 countries.

43 sites in 4 countries

United States33 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anniston, Alabama

  • Study site

    Athens, Ohio

  • Study site

    Aurora, Colorado

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Boston, Massachusetts

  • Study site

    Chicago, Illinois

  • Study site

    College Park, Maryland

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Edina, Minnesota

  • Study site

    El Cajon, California

  • Study site

    Elkridge, Maryland

  • Study site

    Gainesville, Florida

  • Study site

    Garden Grove, California

  • Study site

    High Point, North Carolina

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Laguna Hills, California

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Plano, Texas

  • Study site

    Richmond, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    South Miami, Florida

  • Study site

    Spartanburg, South Carolina

  • Study site

    Walnut Creek, California

  • Study site

    West Jordan, Utah

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

France4 sites

  • Study site

    Limoges

  • Study site

    Montpellier

  • Study site

    Saint-Etienne

  • Study site

    Toulouse

Other trials in France

Netherlands3 sites

  • Study site

    Amsterdam

  • Study site

    Leeuwarden

  • Study site

    Noord-Brabant

Other trials in Netherlands

Spain3 sites

  • Study site

    Albacete

  • Study site

    L'Hospitalet de Llobregat

  • Study site

    Madrid

Other trials in Spain

About this study

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

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.

Conditions
Sarcopenia
Being tested
REGN1033 (SAR391786), placebo
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN1033 (SAR391786)Drug

  • placeboDrug

Study groups in NCT01963598
Study groupRoleWhat they receive
Group 1ExperimentalDosing regimen 1
Receives: Drug: REGN1033 (SAR391786)
Group 2ExperimentalDosing regimen 2
Receives: Drug: REGN1033 (SAR391786); Drug: placebo
Group 3ExperimentalDosing regimen 3
Receives: Drug: REGN1033 (SAR391786); Drug: placebo
Group 4ExperimentalDosing regimen 4
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in total lean body mass

    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).

    Measured: day 1 to day 85

Secondary outcomes (10)

  1. TEAEs

    TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141).

    Measured: day 1 to day 141

  2. Change in appendicular lean mass

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

    Measured: day 1 to day 141

  3. Change in maximal leg press strength (1-RM)

    Change from baseline in maximal leg press strength (1-repetition max)

    Measured: day 1 to day 141

  4. Change in maximal chest press strength (1-RM)

    Change from baseline in maximal chest press strength (1-repetition max)

    Measured: day 1 to day 141

  5. Change in 4M gait speed

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

    Measured: day 1 to day 141

  6. Change in SPPB subscores

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

    Measured: day 1 to day 141

  7. Change in distance walked in the 6MWT

    Change from baseline in distance walked in the 6MWT (6-Minute Walk Test)

    Measured: day 1 to day 141

  8. Change in regional and total fat mass by DEXA

    Change from baseline in regional and total fat mass by DEXA

    Measured: day 1 to day 141

  9. Change in hand grip strength by handheld dynamometer

    Change from baseline in hand grip strength by handheld dynamometer

    Measured: day 1 to day 141

  10. Change in unloaded and loaded stair climb power

    Change from baseline in unloaded and loaded stair climb power

    Measured: day 1 to day 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJan 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01963598
Sponsor's protocol ID
R1033-SRC-1239
Status last verified
Feb 2016
First submitted
11 Oct 2013
Last updated
28 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REGN1033 (SAR391786) in people with Sarcopenia, run by Regeneron Pharmaceuticals at 43 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, France, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in total lean body mass (time frame: day 1 to day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01963598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.

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