Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
Type 1 Hyperlipoproteinemia
About this trial
This is an interventional treatment trial for Type 1 Hyperlipoproteinemia focused on measuring hypertriglyceridemia
Eligibility 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
Sites / Locations
- UT Southwestern Medical Center 5323 Harry Hines Blvd
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
SLx-4090 placebo/Orlistat Placebo
Orlistat/placebo
Orlistat placebo /SLx-4090
Orlistat/SLx-4090
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. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
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. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.