Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01514461 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT01514461: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01514461 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01514461, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia \[HLP\] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).
Primary Outcome
Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.
Interventions
- DRUG Placebo
- DRUG LCQ908
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01514461 record still lists
NCT01514461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01514461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01514461 about?
NCT01514461 is a clinical study titled "A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome". The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia \[HLP\] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as...
What is the current status of trial NCT01514461?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2012-07. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01514461?
The interventions under investigation include: Placebo (DRUG), LCQ908 (DRUG).
Who is sponsoring clinical trial NCT01514461?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01514461's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other 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