Is NCT05816343 recruiting in Dallas, TX?

Yes, NCT05816343 is currently recruiting participants at its Dallas, TX location. This type 1 hyperlipoprotenemia clinical trial is actively enrolling qualified participants.

How do I join the type 1 hyperlipoprotenemia clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Type 1 Hyperlipoprotenemia Clinical Trial in Dallas, TX

About This Type 1 Hyperlipoprotenemia Study in Dallas

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.

Sponsor: University of Texas Southwestern Medical Center

Who Can Participate

Inclusion Criteria

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.

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

Congestive heart failure

Serum creatinine greater than 2.5 mg/dL

Cancer within the past five years

Gastrointestinal surgery in the past

Current therapy with anti-coagulants, digoxin and anti-arrhythmics

Chronic malabsorption syndromes

Cholestasis

Acute illnesses such as acute pancreatitis in the last 8 weeks

Previous history of renal calcium oxalate stones

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT05816343) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 1 Hyperlipoprotenemia Treatment Options in Dallas, TX

If you're searching for type 1 hyperlipoprotenemia treatment options in Dallas, TX, this clinical trial (NCT05816343) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 1 hyperlipoprotenemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 1 hyperlipoprotenemia clinical trials near you to find additional studies recruiting in your area.

Type 1 Hyperlipoprotenemia Clinical Trial in Dallas, TX

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