lomitapide

DRUG13 trials

Sponsors

Aegerion Pharmaceuticals, Inc., Amryt Pharma

Conditions

Effect of Atorvastatin on the Pharmacokinetics of LomitapideFamilial HypercholesterolemiaFamilial Hypercholesterolemia - HomozygousHealthyHealthy VolunteerHomozygous Familial Hypercholesterolaemia (HoFH)Homozygous Familial HypercholesterolemiaIntra-subject Variability of Pharmacokinetics

Phase 1

Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C

CompletedNCT01760187

Aegerion Pharmaceuticals, Inc.Healthy Volunteer

Start: 2012-11-07End: 2013-06-03Updated: 2018-11-20

Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects

CompletedNCT01915771

Aegerion Pharmaceuticals, Inc.Intra-subject Variability of Pharmacokinetics

Start: 2013-07-29End: 2013-08-23Updated: 2020-03-11

A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

CompletedNCT02044419

Aegerion Pharmaceuticals, Inc.Healthy

Start: 2013-10-30End: 2013-12-23Updated: 2018-02-13

Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

CompletedNCT02080468

Aegerion Pharmaceuticals, Inc.Healthy

Start: 2014-02-19End: 2014-04-24Updated: 2019-03-11

Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.

CompletedNCT02080455

Aegerion Pharmaceuticals, Inc.Effect of Atorvastatin on the Pharmacokinetics of Lomitapide

Start: 2014-01-27End: 2014-03-07Updated: 2020-03-10

Phase 2

Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor

CompletedNCT01556906

Aegerion Pharmaceuticals, Inc.Homozygous Familial Hypercholesterolemia

Start: 2003-06-30End: 2004-02-29Updated: 2013-04-10

Phase 3

Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia

CompletedNCT00943306

Aegerion Pharmaceuticals, Inc.Familial Hypercholesterolemia

Start: 2009-10-29End: 2014-12-01Updated: 2018-06-13

Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy

CompletedNCT02173158

Aegerion Pharmaceuticals, Inc.Familial Hypercholesterolemia - Homozygous

Start: 2014-04-02End: 2015-12-17Updated: 2018-10-10

Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy

WithdrawnNCT02765841

Aegerion Pharmaceuticals, Inc.Homozygous Familial Hypercholesterolemia

Start: 2016-05-31End: 2019-12-31Updated: 2018-02-22

Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)

CompletedNCT04681170

Amryt PharmaHomozygous Familial Hypercholesterolaemia (HoFH)

Start: 2020-12-14End: 2024-06-06Updated: 2025-08-27

Unknown Phase

LOWER: Lomitapide Observational Worldwide Evaluation Registry

CompletedNCT02135705

Amryt PharmaHomozygous Familial Hypercholesterolemia

Start: 2014-03-18End: 2026-04-27Updated: 2026-05-12

Effects of Lomitapide on Carotid and Aortic Atherosclerosis

WithdrawnNCT02399852

Aegerion Pharmaceuticals, Inc.Homozygous Familial Hypercholesterolemia

Start: 2015-06-30End: 2021-12-31Updated: 2017-12-15

Global Lomitapide Pregnancy Exposure Registry

TerminatedNCT02399839

Amryt PharmaPregnancy

Start: 2014-10-31End: 2022-12-31Updated: 2022-12-16

Related Papers

Lomitapide for the treatment of paediatric patients with homozygous familial hypercholesterolaemia (APH-19): results from the efficacy phase of an open-label, multicentre, phase 3 study.

2024-10-1611 citations

Long‐term hepatic safety of lomitapide in homozygous familial hypercholesterolaemia

Liver International2022-12-1532 citations

Therapeutic Options for Homozygous Familial Hypercholesterolemia: The Role of Lomitapide.

2020-01-015 citations

Target achievement and cardiovascular event rates with Lomitapide in homozygous Familial Hypercholesterolaemia.

2018-06-2034 citations