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Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

StatusRecruiting
PhasePhase 2
Started2024-01-26
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
Study Status v8
Re-verified, no change to tracked fields
2026-05-27
Study Status, Eligibility, Contacts/Locations v7
Eligibility criteria+1,982 characters
Inclusion criteria: Age ≥ 8 years Type I hyperlipoproteinemia confirmed by bi-allelic disease- [...] he T1HLP genes (LPL, APOC2, APOA5, LMF1, GPIHBP1, or GCKR). Subjects with digenic inheritance with heterozygous disease-causing variants in two different T1HLP genes. Subjects who have a fasting TG greater than or equal to 750 [...] un-in period of 8 weeks will be eligible for randomization. AgeSubjects ≥who do not have confirmed genetic mutation for Type 1 hyperlipoproteinemia but have a fasting TG greater than or equal to 750 mg/dL at the end of run-in period of 8 yearsweeks will be eligible for randomiza [...] [...]
Study sitescontacts updated at 1 of 1 site
2025-05-09
Study Status v6
Primary completion date2025-09-15→2027-08-01
Completion date2025-12-30→2029-05-30
2025-05-04
Study Status, Oversight, Contacts/Locations v5
Primary completion date2025-04-15→2025-09-15
Completion date2025-07-30→2025-12-30
Study sitescontacts updated at 1 of 1 site
2025-03-07
Study Status, Oversight, Eligibility, Contacts/Locations v4
Eligibility criteria+219 characters
Inclusion Criteria: Type I hyperlipoproteinemia confirmed by bi-allelic disease- [...] he T1HLP genes (LPL, APOC2, APOA5, LMF1, GPIHBP1, or GCKR). FastingSubjects serumwho triglyceridehave levelsa offasting TG greater than or equal to 750 mg/dL at the end of run-in period of 8 weeks will be eligible for randomization. Age ≥ 8-70 years EffectiveWell contraceptioncontrolled fordiabetes malesmellitus andwith femaleshemoglobin ofA1c childbearing< age.8% Off orlistat for a period of 2 months. Exclusion Criteria: Secondary hypertriglyceridemiashypertriglyceridemia due to diabetes, renal disease, hypothyroi [...] [...]
Study sitescontacts updated at 1 of 1 site
Show 3 earlier versions
2024-03-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-30→confirmed 2024-01-26
Study sites0→1
2024-01-08
Study Status, Eligibility v2
Start date2023-12-15→2024-01-30
Eligibility criteria-1 characters
[...] or GCKR). Fasting serum triglyceride levels of greater than 1000750 mg/dL. Age 8-70 years Effective contraception for males and [...]
2023-10-11
Study Status v1
Start date2023-04-15→2023-12-15
2023-04-14
Original filing
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.
Trial Details
NCT Number NCT05816343
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Type 1 Hyperlipoprotenemia
Enrollment 28 participants
Start Date 2024-01-26
Primary Completion 2027-08-01 (estimated)
Study Completion 2029-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21