NCT02767531 (T1HLP) is a Phase 2 clinical trial of Orlistat in Hyperlipoproteinemia Type I, sponsored by University of Texas Southwestern Medical Center.

Who is sponsoring NCT02767531?

NCT02767531 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT02767531?

Interventions in NCT02767531: Orlistat.

What condition does NCT02767531 study?

NCT02767531 studies Hyperlipoproteinemia Type I, Hypertriglyceridemia.

Is NCT02767531 still recruiting?

NCT02767531 is currently completed. Last updated 6 February 2023.

Are results published for NCT02767531?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-06 · How we verify

NCT02767531: T1HLP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Orlistat for the Treatment of Type I Hyperlipoproteinemia

Completed Phase 2 Results posted Last updated 6 February 2023

What this trial tests

Phase 2 trial testing Orlistat in Hyperlipoproteinemia Type I in 2 participants. Completed in 31 December 2022.

Timeline

1 December 2015

Primary endpoint
31 May 2018

31 December 2022

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	1 December 2015
Primary completion	31 May 2018
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

Orlistat — full drug profile →

Conditions studied

Hyperlipoproteinemia Type I — all drugs for Hyperlipoproteinemia Type I →
Hypertriglyceridemia — all drugs for Hypertriglyceridemia →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 8 to 18, any sex, with Hyperlipoproteinemia Type I or Hypertriglyceridemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Fasting Serum Triglycerides
Time frame: 3 days
Fasting blood samples were collected on three consequetive days at the end of each three month period. Mean values of the three days were calculated.

Sponsor's own description

Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a challenge to treat, as the only effective therapy available is an extremely low fat diet. This diet is exceedingly difficult to follow, and despite adherence, many patients still have chylomicronemia and develop acute pancreatitis. Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor, Orlistat, in reducing serum triglyceride levels in patients with T1HLP.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Orlistat Therapy for Children With Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial.
Patni N, Quittner C, Garg A. · · 2018 · cited 11× · PMID 29659879 · DOI 10.1210/jc.2018-00369

Verify or expand the search:

Other trials of Orlistat

Trials testing the same drug.

NCT06854614 — Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic · Phase 4 · active not recruiting
NCT05816343 — Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia · Phase 2 · recruiting
NCT06501326 — Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease · Phase 4 · unknown
NCT05579249 — A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America · Phase 4 · completed
NCT05496075 — Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia · Phase 4 · completed

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02767531 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 6 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02767531.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing