Trial · NCT01963598
Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
NCT01963598, Phase 2, Completed, Regeneron Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia. Trials, record NCT01963598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01963598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
- NCT number
- NCT01963598
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 253 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Sarcopenia
- Interventions
- REGN1033 (SAR391786), placebo
- First posted
- 2013-10-16
- Last updated
- 2016-03-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change in total lean body mass | 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 | TEAEs | day 1 to day 141 | TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141). |
| Secondary | Change in appendicular lean mass | day 1 to day 141 | Changes from baseline (day 1) in appendicular lean mass by DEXA |
| Secondary | Change in maximal leg press strength (1-RM) | day 1 to day 141 | Change from baseline in maximal leg press strength (1-repetition max) |
| Secondary | Change in maximal chest press strength (1-RM) | day 1 to day 141 | Change from baseline in maximal chest press strength (1-repetition max) |
| Secondary | Change in 4M gait speed | day 1 to day 141 | Change from baseline in 4-meter (4M) gait speed |
| Secondary | Change in SPPB subscores | day 1 to day 141 | Change from baseline in SPPB (Short Physical Performance Battery) subscores |
| Secondary | Change in distance walked in the 6MWT | day 1 to day 141 | Change from baseline in distance walked in the 6MWT (6-Minute Walk Test) |
| Secondary | Change in regional and total fat mass by DEXA | day 1 to day 141 | Change from baseline in regional and total fat mass by DEXA |
| Secondary | Change in hand grip strength by handheld dynamometer | day 1 to day 141 | Change from baseline in hand grip strength by handheld dynamometer |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01963598
GET https://conductscience.org/api/trials/v1/NCT01963598/registered