Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
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|ClinicalTrials.gov Identifier: NCT01675154|
Recruitment Status : Recruiting
First Posted : August 29, 2012
Last Update Posted : October 12, 2018
Funding Source - FDA OOPD
This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can treat the high blood fat (elevated triglycerides)levels found in the condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone, the current standard medical care.
It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The researchers are interested in learning whether any one of these drugs when given alone or in combination is more effective and safe in treating T1HLP.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Hyperlipoproteinemia||Drug: SLx-4090 placebo Drug: Orlistat Placebo Drug: Orlistat Drug: Slx-4090||Phase 2|
Type I hyperlipoproteinemia is a rare, autosomal recessive metabolic disorder characterized by extreme hypertriglyceridemia due to a deficiency in lipoprotein lipase or related proteins. Treatment of these patients is challenging as triglyceride-lowering medications are ineffective. A low fat diet is helpful, however, despite good dietary compliance, some patients continue to have severe hypertriglyceridemia and recurrent pancreatitis which can be life threatening. Therefore, we wish to investigate whether inducing dietary fat malabsorption or inhibiting chylomicron formation will cause further lowering of serum triglycerides (TG) beyond the effect of limiting dietary fat intake.
We will study the efficacy and safety of an inhibitor of intestinal lipase (Orlistat) and an intestinal-specific inhibitor of microsomal triglyceride transport protein (MTP) involved in the assembly and secretion of chylomicrons (SLx-4090), alone and in combination, for reducing serum triglyceride levels in patients with Type I hyperlipoproteinemia. We plan to enroll 20 patients with Type I hyperlipoproteinemia in a randomized, double-blind, placebo-controlled, cross-over trial. After a baseline evaluation, the subjects will be randomly assigned to placebo/placebo, Orlistat/placebo, SLx-4090/placebo or Orlistat/SLx-4090 for the duration of four weeks followed by a one week wash out period. During the last week of each study period, fasting blood samples will be drawn for three consecutive days for serum lipids and chemistry panel. The primary endpoint will be serum triglycerides; the secondary endpoint variables will be fasting and postprandial serum chylomicron-TG levels, postprandial serum TG levels during a meal tolerance test and retinyl palmitate levels during a meal tolerance test. Repeated measures analysis of variance will be used for statistical comparisons.
Our results may help in designing novel therapeutic approaches for patients with Type 1 hyperlipoproteinemia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study of Orlistat and SLx-4090 for Teh Treatment of Type 1 Hyperlipoproteinemia|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Placebo Comparator: SLx-4090 placebo/Orlistat Placebo
Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals.
Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals.
Drug: SLx-4090 placebo
Drug: Orlistat Placebo
Active Comparator: Orlistat/placebo
Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals.
Drug: SLx-4090 placebo
Active Comparator: Orlistat placebo /Slx-4090
Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals.
Drug: Orlistat Placebo
Active Comparator: Orlistat/SLx-4090
Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals.
- Change in serum triglycerides from baseline for each crossover arm phase of placebo/placebo, orlistat/placebo, orlistat/SLx-4090, SLx-4090/placebo [ Time Frame: Every every 4 weeks at the end of each phase for 3 draws ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675154
|Contact: Claudia Quittner, RN, BSN, MSfirstname.lastname@example.org|
|Contact: Chandna Vasandani, Ph.Demail@example.com|
|United States, Texas|
|UT Southwestern Medical Center 5323 Harry Hines Blvd||Recruiting|
|Dallas, Texas, United States, 75390-8537|
|Principal Investigator: Abhimanyu Garg, MD|
|Sub-Investigator: Nivedita Patni, M.D.|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Claudia Quittner, RN 214-648-9296 firstname.lastname@example.org|
|Principal Investigator:||Abhimanyu Garg, MD||UT Southwestern Medical Center|