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NCT05816343 · ClinicalTrials.gov registry record · Phase 2
Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia
A Phase 2 study of Type 1 Hyperlipoprotenemia, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05816343 is a Phase 2 study of Type 1 Hyperlipoprotenemia that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05816343, a Phase 2 study of Type 1 Hyperlipoprotenemia, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Type I hyperlipoproteinemia (T1HLP, also known as familial chylomicronemia syndrome or FCS) is a rare diseasewhere the blood triglycerides (fats) are very high. It is caused by lack of certain enzymes and proteins in the bodythat are important in disposing circulating fats from blood. Treatment of T1HLP patients who have very high levels of blood fats (≥ 1,000 mg/dL) is challenging as conventional triglyceride-lowering medications, such as fibrates and fishoil, are ineffective. The purpose of this trial is to study the long-term efficacy and safety of orlistat for reducing blood triglyceride levels in patients with T1HLP.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Orlistat
Study Locations (1)
Texas
- UT southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-01-26 |
| Est. Completion | 2029-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05816343
The ClinicalTrials.gov registry entry for NCT05816343 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Hyperlipoprotenemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05816343 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05816343 about?
NCT05816343 is a clinical study titled "Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia". Type I hyperlipoproteinemia (T1HLP, also known as familial chylomicronemia syndrome or FCS) is a rare diseasewhere the blood triglycerides (fats) are very high. It is caused by lack of certain enzymes and proteins in the bodythat are important in disposing circulating fats from blood. Treatment of T...
What is the current status of trial NCT05816343?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2024-01-26. Estimated completion is 2029-05-30.
What conditions does trial NCT05816343 study?
This clinical trial studies the following conditions: Type 1 Hyperlipoprotenemia.
What interventions are being tested in trial NCT05816343?
The interventions under investigation include: Placebo (DRUG), Orlistat (DRUG).
Who is sponsoring clinical trial NCT05816343?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05816343 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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