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NCT03397121 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
A Phase 3 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 482
- Enrollment target
NCT03397121: Completed Phase 3 study, sponsored by The Medicines Company.
NCT03397121 is a Phase 3 study that has completed, run by The Medicines Company. The registered enrollment target is 482 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03397121, a Phase 3 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 482 participants
- Enrollment target
Study Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
Interventions
- DRUG Placebo
- DRUG Inclisiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2019-09-17 |
| Phase | Phase 3 |
What the finished NCT03397121 record still lists
NCT03397121 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03397121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03397121 about?
NCT03397121 is a clinical study titled "Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)". This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
What is the current status of trial NCT03397121?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 482 participants. The study started on 2017-11-28. Estimated completion is 2019-09-17.
What interventions are being tested in trial NCT03397121?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT03397121?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03397121's enrollment target sits among peer trials
482 792nd of 2000 higher than 1,209 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
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