NCT05816343|RecruitingPhase 2DMCFDA Drug
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Sponsor study identifier
interventional
28
1 country
1
Study Start
January 26, 2024
Actual (reported)Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2023
Actual (reported)April 18, 2023
Actual (reported)January 26, 2024
Actual (reported)August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Triglycerides
Change in fasting serum TG levels weeks compared to the baseline fasting serum TG levels .
24 weeks
Drug will be given orally.
Placebo will be given orally.
Orlistat is an inhibitor of gastric and pancreatic lipases and can reduce dietary fat absorption by 30%. Orlistat at a dose of 2 capsules (each containing 60 mg of active drug) three times a day with each meal (a total dose of 360 mg daily).
Placebo at a dose of 2 capsules (each containing 60 mg placebo) three times a day with each meal (a total dose of 360 mg daily).
UT southwestern Medical Center
Dallas, Texas, 75390, United States
Abhimanyu G Garg, MD
University of Texas Southwestern Medical Center
Chandna Vasandani, Ph.D
University of Texas Southwestern Medical Center
First Submitted
April 1, 2023
First Posted
April 18, 2023
Study Start
January 26, 2024
Actual (reported)Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 21, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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