Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Type 1 Hyperlipoprotenemia, sponsored by University of Texas Southwestern Medical Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in fasting serum TG levels weeks compared to the baseline fasting serum TG levels .
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 |
What NCT05816343 shows while recruiting
NCT05816343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05816343's enrollment target sits among peer trials
28 1677th of 2000 higher than 305 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
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI