NCT02767531|CompletedPhase 2ResultsDMC
Orlistat for the Treatment of Type I Hyperlipoproteinemia
T1HLP
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Sponsor study identifier
interventional
2
1 country
1
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 31, 2018
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a challenge to treat, as the only effective therapy available is an extremely low fat diet. This diet is exceedingly difficult to follow, and despite adherence, many patients still have chylomicronemia and develop acute pancreatitis. Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor, Orlistat, in reducing serum triglyceride levels in patients with T1HLP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 2, 2016
Actual (reported)May 10, 2016
Actual (reported)May 31, 2018
Actual (reported)February 1, 2019
Actual (reported)December 31, 2022
Actual (reported)Fasting Serum Triglycerides
Fasting blood samples were collected on three consequetive days at the end of each three month period. Mean values of the three days were calculated.
3 days
120 mg of Orlistat will be given 3 times to patients weighing greater than 50 kg and patients weighing less than 40 kg will be given 60 mg of Orlistat 3 times a day for 3 months.
Standard therapy will be given for three months
Orlistat is a gastric and pancreatic lipase inhibitor that is approved by the FDA for weight loss. It is available over-the-counter as 60 mg tablets under the trade name Alli, and available by prescription as 120 mg capsules under the trade name Xenical.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UT Southwestern Medical Center 5323 Harry Hines Blvd
Dallas, Texas, 75390-8537, United States
Patni N, Quittner C, Garg A. Orlistat Therapy for Children With Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2403-2407. doi: 10.1210/jc.2018-00369.
Abhimanyu Garg, MD
University of Texas
2 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2016
First Posted
May 10, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2018
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
February 8, 2023
Results First Posted
February 1, 2019
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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