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Lipase Inhibitor

Orlistat for High Cholesterol

Phase 2
Recruiting
Led By Abhimanyu G Garg, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial is looking at whether orlistat can help lower blood triglyceride levels in patients with Type I hyperlipoproteinemia, a rare disease where blood fats are very high due to a

Who is the study for?
This trial is for people aged 8-70 with a rare condition called Type I hyperlipoproteinemia, confirmed by specific genetic variants. They must have very high blood fat levels (≥1000 mg/dL) and not have taken orlistat recently. Both men and women of childbearing age should use effective contraception.
What is being tested?
The trial is testing the long-term effectiveness and safety of a drug called orlistat in reducing extremely high triglyceride (blood fat) levels in patients with Type I hyperlipoproteinemia, compared to a placebo.
What are the potential side effects?
Orlistat may cause digestive side effects like stomach pain, gas, diarrhea, oily spotting on underwear, and difficulty controlling bowel movements. It might also interfere with the absorption of some vitamins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Triglycerides

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Orlistat DrugActive Control1 Intervention
Drug will be given orally.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be given orally.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,161 Total Patients Enrolled
1 Trials studying Hypercholesterolemia
Chandna Vasandani, Ph.DStudy DirectorUT Southwestern Medical Center
Abhimanyu G Garg, MDPrincipal InvestigatorUT Southwestern Medical Center
~8 spots leftby Apr 2025
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