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Recruiting Phase 2 Interventional

Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

ClinicalTrials.gov ID: NCT05816343

Public ClinicalTrials.gov record NCT05816343. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 10:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia: a Randomized, Double-blind, Placebo-controlled Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05816343
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
28 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
8 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 25, 2024
Primary completion
Jul 31, 2027
Completion
May 29, 2029
Last update posted
Jul 20, 2026

2024 – 2029

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UT southwestern Medical Center Dallas Texas 75390 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05816343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 20, 2026 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05816343 live on ClinicalTrials.gov.

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