Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01963598 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 253
- Enrollment target
NCT01963598: Completed Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT01963598 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 253 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01963598, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 253 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG placebo
- DRUG REGN1033 (SAR391786)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT01963598 record still lists
NCT01963598 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01963598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01963598 about?
NCT01963598 is a clinical study titled "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.
What is the current status of trial NCT01963598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 253 participants. The study started on 2013-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01963598?
The interventions under investigation include: placebo (DRUG), REGN1033 (SAR391786) (DRUG).
Who is sponsoring clinical trial NCT01963598?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01963598's enrollment target sits among peer trials
253 220th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04390737 · 254 participants · Phase 1
Evaluate the Safety and Clinical Activity of HH2853
- NCT04677647 · 254 participants · NA
OurChild: A Health IT Solution to Reduce Minority Health Disparities
- NCT05503797 · 254 participants · Phase 2
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
- NCT06167317 · 254 participants · Phase 1
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia