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Gastric and Pancreatic Lipase Inhibitor

Orlistat for Hypercholesterolemia (T1HLP Trial)

Phase 2

Waitlist Available

Led By Abhimanyu 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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

T1HLP Trial Summary

This trial is testing a new treatment for Type I Hyperlipoproteinemia, a rare form of hypertriglyceridemia. The new treatment is a gastric and pancreatic lipase inhibitor called Orlistat. The trial will test the efficacy of Orlistat in reducing serum triglyceride levels in patients with T1HLP.

Eligible Conditions

Hypercholesterolemia
High Triglycerides

T1HLP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Fasting Serum Triglycerides

T1HLP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OrlistatExperimental Treatment1 Intervention

120 mg of Orlistat will be given 3 times to patients weighing greater than 50 kg and patients weighing less than 40 kg will be given 60 mg of Orlistat 3 times a day for 3 months.

Group II: Off drugActive Control1 Intervention

Standard therapy will be given for three months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orlistat

2022

Completed Phase 4

~1490

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,797 Total Patients Enrolled

1 Trials studying Hypercholesterolemia

Abhimanyu Garg, MDPrincipal InvestigatorUniversity of Texas

5 Previous Clinical Trials

55 Total Patients Enrolled

Frequently Asked Questions

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

Does this experiment currently have capacity for more participants?

"The research project, which was initially posted in December 2015 and recently revised on January 23rd 2022, is no longer actively recruiting. However, there are presently 76 other trials that require participants."

Answered by AI

What therapeutic purpose does Orlistat serve?

"Orlistat is frequently prescribed to patients with a BMI of over 27 kg/m2. Additionally, this medication can assist those attempting to reduce their weight and even individuals hoping to gain it, along with managing other medical issues."

Answered by AI

Is it possible for me to participate in this clinical experiment?

"To be suitable for this particular research program, potential participants must have hyperlipoproteinemia type i and fall within the age bracket of 8 to 18. The project is seeking a total of 2 enrollees."

Answered by AI

Are there any prior experiments in which Orlistat was used?

"At present, there are 2 clinical trials for Orlistat in progress with none of them at Phase 3. Locations hosting these medical studies include Cleveland, Ohio and one other site yet to be specified."

Answered by AI

What is the maximum number of individuals being accepted into this clinical research study?

"Unfortunately, this clinical trial has ceased recruiting patients. Initially posted on December 1st 2015 and last updated on January 23rd 2022, it is no longer accepting applicants. Nevertheless, there appear to be 74 studies for hyperlipoproteinemia type I actively enrolling as well as 2 trials involving Orlistat that are still open to enrollment."

Answered by AI

Has Orlistat been approved by the U.S. Food & Drug Administration?

"Due to limited data regarding efficacy, the safety of Orlistat was evaluated at a 2 on our scale. Nonetheless, there is evidence attesting to its security from Phase 2 trials."

Answered by AI

Does the protocol of this investigation permit participation by individuals over two decades old?

"Potential participants in this trial must be between 8-18 years old. There are 7 trials specifically for minors, and 65 clinical studies that accept seniors as candidates."

Answered by AI

Recent research and studies

The Journal of Clinical Endocrinology & MetabolismJournal

Orlistat Therapy for Children with Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial

Patni, Nivedita, Claudia Quittner, and Abhimanyu Garg. 2018. “Orlistat Therapy for Children with Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2018-00369.

clinicaltrials.govStudy

Orlistat for the Treatment of Type I Hyperlipoproteinemia

Abhimanyu Garg 2015. "Orlistat for the Treatment of Type I Hyperlipoproteinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02767531.