TerminatedPhase 2

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Stopped: Due to unavailability of the drug.

United States5 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range

12 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum Triglycerides at First Intervention Period

Timeframe: 4 weeks after the assigned treatment (first intervention period)

Serum Triglycerides at Second Intervention Period

Timeframe: 4 weeks after the assigned treatment (Second Intervention Period)

Serum Triglycerides at Third Intervention Period

Timeframe: 4 weeks after the assigned treatment (Third Intervention Period)

Serum Triglycerides at Fourth Intervention Period

Timeframe: 4 weeks after the assigned treatment (Fourth Intervention Period)

Trial details

NCT IDNCT01675154

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

Results submitted2021-05-21

View on ClinicalTrials.gov More Type 1 Hyperlipoproteinemia trials