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Trial record 17 of 70 for:    ORLISTAT

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
Sponsor:
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arm Intervention/treatment
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
Drug: Orlistat
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
Drug: Slx-4090
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.
Drug: Orlistat
Drug: Slx-4090



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type I hyperlipoproteinemia.
  • Fasting serum triglyceride levels of greater than 1000 mg/dL.
  • Age > 12 years

Exclusion Criteria:

  • Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism, alcoholism and drug therapy such as estrogens and estrogen analogues, steroids, HIV-protease inhibitors, retinoic acid derivatives and interferons.
  • Pregnant or lactating women
  • Significant liver disease (elevated transaminases > 2 times upper limit of normal)
  • Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks for men or 168 g per week for men)
  • Drug use (cocaine, marijuana, LSD, etc.)
  • Major surgery in the past three months
  • Congestive heart failure
  • Serum creatinine greater than 2.5 mg/dL
  • Cancer within the past five years
  • Gastrointestinal surgery in the past
  • Current therapy with anti-coagulants, digoxin and anti-arrhythmics
  • Chronic malabsorption syndromes
  • Cholestasis
  • Acute illnesses such as acute pancreatitis in the last 8 weeks

Information from the National Library of Medicine

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


Contacts
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Contact: Claudia Quittner, RN, BSN, MS 214-648-9296 claudia.quittner@utsouthwestern.edu
Contact: Chandna Vasandani, Ph.D 214-648-5074 chandna.vasandani@utsouthwestern.edu

Locations
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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    claudia.quittner@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Abhimanyu Garg, MD UT Southwestern Medical Center

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Responsible Party: Abhimanyu Garg, PI, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01675154     History of Changes
Other Study ID Numbers: 3940
FD-R-003940
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Abhimanyu Garg, University of Texas Southwestern Medical Center:
hypertriglyceridemia
Additional relevant MeSH terms:
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Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents