CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Orlistatdrug
Likely dose
Orlistat 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02767531
NCT02767531Phase 2Completed

Orlistat for the Treatment of Type I Hyperlipoproteinemia

University of Texas Southwestern Medical Center·interventional·Posted May 10, 2016·Updated Feb 8, 2023

In Brief

A Phase 2 clinical trial evaluating Orlistat for Hyperlipoproteinemia Type I and Hypertriglyceridemia. Completed, enrolled 2 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 10, 2016
Enrollment StartDec 1, 2015
Primary CompletionMay 31, 2018
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.1 years ago

Interventions

Orlistatdrug

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.