16 completed, 2 withdrawn, 1 recruiting. 6 Phase 2, 5 Phase 1, 4 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 6 |
| Phase 1 | 5 | Completed 5 |
| Phase 3 | 4 | Completed 3, Withdrawn 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy Metreleptin - Generalized Lipodystrophy | Phase 4 | Completed | Aegerion Pharmaceuticals, Inc. | 11 | 2018-11-14 | 2025-11-26 |
| Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy Lomitapide - Homozygous Familial Hypercholesterolemia | Phase 3 | Withdrawn | Aegerion Pharmaceuticals, Inc. | 2016-05-01 | 2018-02-22 | |
| Effects of Lomitapide on Carotid and Aortic Atherosclerosis Lomitapide - Homozygous Familial Hypercholesterolemia | Withdrawn | Aegerion Pharmaceuticals, Inc. | 2015-06-01 | 2017-12-15 | ||
| Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy lomitapide - Familial Hypercholesterolemia - Homozygous | Phase 3 | Completed | Aegerion Pharmaceuticals, Inc. | 9 | 2014-04-02 | 2018-10-10 |
| Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects lomitapide, EE/norgestimate - Healthy | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 32 | 2014-02-19 | 2019-03-11 |
| Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects. lomitapide, Atorvastatin - Effect of Atorvastatin on the Pharmacokinetics of Lomitapide | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 32 | 2014-01-27 | 2020-03-10 |
| Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada Familial Hypercholesterolemia, Lipid Disorder | Recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 6000 | 2013-11-01 | 2023-10-04 | |
| A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled lomitapide - Healthy | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 32 | 2013-10-30 | 2018-02-13 |
| Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects lomitapide - Intra-subject Variability of Pharmacokinetics | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 15 | 2013-07-29 | 2020-03-11 |
| Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C lomitapide - Healthy Volunteer | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 72 | 2012-11-07 | 2018-11-20 |
| Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia lomitapide - Familial Hypercholesterolemia | Phase 3 | Completed | Aegerion Pharmaceuticals, Inc. | 19 | 2009-10-29 | 2018-06-13 |
| Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia Atorvastatin, AEGR-733 - Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 44 | 2008-05-01 | 2018-02-23 |
| A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH) AEGR-733 - Homozygous Familial Hypercholesterolemia | Phase 3 | Completed | Aegerion Pharmaceuticals, Inc. | 29 | 2007-12-01 | 2018-03-20 |
| Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS AEGR-733, placebo, AEGR-733 and atorvastatin - Hyperlipidemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 260 | 2007-10-01 | 2018-02-23 |
| AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia Atorvastatin 20 mg, AEGR-733 5 mg, AEGR-733 10 mg - Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 157 | 2007-04-01 | 2018-03-20 |
| The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia BMS-201038 (AEGR-733), Ezetimibe - Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 60 | 2006-05-01 | 2014-03-04 |
| Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents atorvastatin, simvastatin, ezetimibe - Healthy | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 125 | 2006-03-01 | 2018-02-23 |
| Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor Lomitapide - Homozygous Familial Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 6 | 2003-06-01 | 2013-04-10 |
| Detection of Familial Hypercholesterolaemia in Cardiovascular Disease Registry Familial Hypercholesterolemia, Cardiac Event | Completed | University College, London | 1622948 | 2003-01-01 | 2016-05-20 |
Homozygous Familial Hypercholesterolemia (6) · Hypercholesterolemia (4) · Hyperlipoproteinemia Type II (3) · Hyperlipidemias (2) · Cardiovascular Diseases (1) · Coronary Artery Disease (1) · Lipid Metabolism Disorders (1) · Lipodystrophy (1) · Lipodystrophy, Congenital Generalized (1)
BMS201038 (15) · Atorvastatin (5) · Ezetimibe (3) · Fenofibrate (2) · Dextromethorphan (1) · Simvastatin (1) · metreleptin (1)
United States (11) · Canada (3) · United Kingdom (3) · Italy (2) · South Africa (2) · Japan (1)
Mark Sumeray, MD (6) · Marina Cuchel, MD, PhD (3) · T. Alex King, MD, CPI (2) · Ulrike Lorch, MD (2) · Barry Lubin, MD (1) · Dan J Rader, MD (1) · Eli Roth, MD (1) · Jackson Downey, MD (1) · Jacques Genest, MD (1) · James McKenney, Pharm D (1) · Janet Boylan (1) · John Deanfield, MD (1) · Joy Ayemoba, MSc (1) · Mariko Harada-Shiba, M.D., Ph.D. (1) · Michael Davidson, MD (1)
PMID 36520008, PMID 17215532, PMID 25897792, PMID 26723464, PMID 37607748