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Lipase Inhibitor

Orlistat Drug for Hypercholesterolemia

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,707 Total Patients Enrolled

1 Trials studying Hypercholesterolemia

Chandna Vasandani, Ph.DStudy DirectorUT Southwestern Medical Center

Abhimanyu G Garg, MDPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being recruited for this clinical trial?

"According to information available on clinicaltrials.gov, patient recruitment is ongoing for this current clinical trial. The study was first listed on 1/26/2024 and most recently revised on 3/4/2024."

Answered by AI

What are the potential risks associated with using the medication Orlistat in patients?

"The safety assessment for the Orlistat Drug is rated at 2 by our team, based on it being a Phase 2 trial. This indicates that there exists preliminary data to support its safety profile but no evidence yet regarding its effectiveness."

Answered by AI

Are individuals above the age of 65 being actively sought for participation in this medical study?

"Individuals aged between 8 and 70 are eligible for enrolment in this research project. There are a total of 4 studies targeting participants under the age of majority, alongside 44 trials focused on individuals over the age of retirement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

Abhimanyu Garg 2024. "Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05816343.

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