Who is eligible for clinical trial NCT05816343?

Participants must meet protocol criteria for Type 1 Hyperlipoprotenemia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05816343 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-17

Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia (NCT05816343)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Texas Southwestern Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (21 items).

Location: UT southwestern Medical Center — Dallas, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥ 8 years
Type I hyperlipoproteinemia confirmed by bi-allelic disease-causing variants in any one of the 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 mg/dL at the end of run-in period of 8 weeks will be eligible for randomization.
Subjects 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 weeks will be eligible for randomization.
Well controlled diabetes mellitus with hemoglobin A1c \< 8%
Off orlistat for a period of 2 months
Patients on Olezarsen and Plozasiran (APOC3 antisense oligonucleotide) can enroll if on the drug for more than 3 months
Following methods of contraception for males and females of childbearing age will be employed Males: Being in this research may damage your sperm, which could cause harm to a child that you may father while on this study. If you take part in this study and are sexually active, you must agree to use a medically-acceptable form of birth control. Medically-acceptable forms of birth control include: (1) surgical sterilization (vasectomy), or (2) a condom used with a spermicide (a substance that kills sperm). Females: If you are part of this study while pregnant or breast-feeding an infant, it is possible that you may expose the unborn child or infant to risks. For that reason, pregnant and breast-feeding females cannot participate in the study. If you can become pregnant, a blood or urine pregnancy test will be done, and it must be negative before you participate in this study. If you take part in this study and you are sexually active, you and any person that you have sex with must use medically-acceptable birth control (contraceptives) during the study. Medically-acceptable birth control (contraceptives) includes: (1) surgical sterilization (such as hysterectomy or "tubes tied"), (2) approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), (3) barrier methods (such as condom or diaphragm) used with a spermicide (a substance that kills sperm), or (4) an intrauterine device (IUD). If you do become pregnant during this study, you must tell the researchers immediately.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Secondary hypertriglyceridemia due to diabetes, renal disease, alcoholism and drug therapy such as estrogens and estrogen analogues, steroids, HIV-1 protease inhibitors, retinoic acid derivatives, interferons, or lasparaginase.
On lomitapide or participating in clinical trial of volanesorsen.
On cyclosporine
Having serum TSH outside of the normal range if on levothyroxine supplementation.
Use of levothyroxine to suppress TSH in individuals with thyroid cancer.
Pregnant or lactating women
Significant liver disease (elevated transaminases \> 2 times upper limit of normal)
Alcohol abuse (\> 7 drinks or 84 g per week for women and \> 14 drinks or 168 g per week for men)
Severe anemia (hematocrit \< 24%)
Illicit drug use (cocaine, marijuana, LSD, etc.)
Major surgery in the past three months

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

UT southwestern Medical Center — Dallas, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗