RECRUITING

Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-26
Study Completion:2025-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05816343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Type I hyperlipoproteinemia confirmed by bi-allelic disease-causing variants in any one of the T1HLP genes (LPL, APOC2, APOA5, LMF1, GPIHBP1, or GCKR).
  2. 2. Fasting serum triglyceride levels of greater than 750 mg/dL.
  3. 3. Age 8-70 years
  4. 4. Effective contraception for males and females of childbearing age.
  5. 5. Off orlistat for a period of 2 months.
  1. * Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism, alcoholism and drug therapy such as estrogens and estrogen analogues, steroids, HIV-1 protease inhibitors, retinoic acid derivatives, interferons, or l-asparaginase.
  2. * On lomitapide or participating in clinical trial of volanesorsen
  3. * Pregnant or lactating women
  4. * Significant liver disease (elevated transaminases \> 2 times upper limit of normal)
  5. * Alcohol abuse (\> 7 drinks or 84 g per week for women and \> 14 drinks or 168 g per week for men)
  6. * Severe anemia (hematocrit \< 24%)
  7. * Illicit drug use (cocaine, marijuana, LSD, etc.)
  8. * Major surgery in the past three months
  9. * Congestive heart failure
  10. * Serum creatinine greater than 2.5 mg/dL
  11. * Cancer within the past five years
  12. * Gastrointestinal surgery in the past
  13. * Current therapy with anti-coagulants, digoxin and anti-arrhythmics
  14. * Chronic malabsorption syndromes
  15. * Cholestasis
  16. * Acute illnesses such as acute pancreatitis in the last 8 weeks
  17. * Previous history of renal calcium oxalate stones

Contacts and Locations

Study Contact

Abhimanyu G [agarg], MD
CONTACT
2146482895
abhimanyu.garg@utsouthwestern.edu
Abhimanyu G [agarg]
CONTACT
2146482895
abhimanyu.garg@utsouthwestern.edu

Principal Investigator

Abhimanyu G Garg, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Chandna Vasandani, Ph.D
STUDY_DIRECTOR
UT Southwestern Medical Center

Study Locations (Sites)

UT southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Abhimanyu G Garg, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center
  • Chandna Vasandani, Ph.D, STUDY_DIRECTOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-26
Study Completion Date2025-07-30

Study Record Updates

Study Start Date2024-01-26
Study Completion Date2025-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Hyperlipoprotenemia