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NCT03405870 · ClinicalTrials.gov registry record · Phase 1

LIPIDS-P Trial Phase I/II Trial

A Phase 1 study, sponsored by University of Florida.

Completed
Registry status
Phase 1
Development phase
59
Enrollment target

NCT03405870: Completed Phase 1 study, sponsored by University of Florida.

NCT03405870 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03405870, a Phase 1 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 1
Development phase
59 participants
Enrollment target

Study Summary

Briefly, this pilot clinical trial will evaluate preliminary safety and efficacy of the study drug (Smoflipid) at elevating cholesterol levels (primary outcome) in patients with sepsis and moderate organ dysfunction and will also evaluate measures of organ dysfunction, mortality, and biological activity (secondary outcomes).

Primary Outcome

Change in total cholesterol (48 hour - enrollment value) of 0 to +5 mg/dL

Interventions

  • DRUG Smoflipid

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2018-08-17
Est. Completion 2023-04-26
Phase Phase 1
University of Florida

1,106 total trials

What the finished NCT03405870 record still lists

NCT03405870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Smoflipid is the first listed.

NCT03405870 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03405870 about?

NCT03405870 is a clinical study titled "LIPIDS-P Trial Phase I/II Trial". Briefly, this pilot clinical trial will evaluate preliminary safety and efficacy of the study drug (Smoflipid) at elevating cholesterol levels (primary outcome) in patients with sepsis and moderate organ dysfunction and will also evaluate measures of organ dysfunction, mortality, and biological acti...

What is the current status of trial NCT03405870?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2018-08-17. Estimated completion is 2023-04-26.

What interventions are being tested in trial NCT03405870?

The interventions under investigation include: Smoflipid (DRUG).

Who is sponsoring clinical trial NCT03405870?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03405870's enrollment target sits among peer trials

59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT03405870, the US trial registry maintained by the National Library of Medicine. NCT03405870 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.