Physician’s Resources
Welcome to Aegerion's health care professional area. Here you can find more information about clinical development of our investigational, orphan drug, therapy, lomitapide as well as links to some of the important professional, advocacy, education and support groups who provide information regarding diagnosis and treatment of patients with hypercholesterolemia, hypertriglyceridemia and orphan indications such as HoFH and FC.
If you’d like to receive updates regarding new Aegerion-sponsored clinical trials, please complete the Clinical Updates Form. If you'd like to speak with one of our clinical operations professionals about qualifying as a site, inquire about compassionate use INDs, or have other questions for our clinical staff, send us an e-mail at clinical@aegerion.com
Aegerion has several ongoing and planned adult and pediatric clinical trials designed to evaluate our orphan drug candidate, lomitapide in genetic lipid disorders. Lomitapide works by reducing lipid levels in the blood by preventing the liver and intestines from secreting lipids into the blood stream. Lomitapide has been evaluated in over 703 patients in seven Phase I studies and six Phase II studies. One of the Phase II studies examined the safety and efficacy of lomitapide in patients with HoFH and five of the Phase II studies were in subjects with moderate hypercholesterolemia. In addition there is an on-going pivotal Phase III study in HoFH patients. A summary table of the clinical trials is shown below.
CV145-001
Single, Oral Dose,
placebo-controlled |
I |
Safety & tolerability |
55 Healthy subjects with increased cholesterol levels |
CV 145-002
Multiple Dose, Oral,
placebo-controlled |
I |
Safety & tolerability of ascending dosages |
36 hypercholesterolemic healthy subjects |
CV 145-003
Single Dose ,IV |
I |
Safety & tolerability of IV administration |
32 hypercholesterolemic healthy subjects |
CV 145-005
Single, Oral Dose |
I |
Pharmacokinetics |
25 healthy subjects |
CV 145-006
Single Dose, Oral |
I |
Absorption, Distribution, Metabolism & Excretion |
6 healthy subjects |
CV 145-010
Multiple Dose, Oral,
placebo controlled |
I |
|
19 healthy females with increased cholesterol levels |
AEGR-733-002
Impact of Multiple Doses on the single-dose pharmacokinetics of common lipid lowering therapies |
I |
Pharmacokinetics |
76 male
53 female normal healthy subjects |
| UP1001 |
II |
Proof of concept |
6 patients with HoFH |
CV 145-009
Single dose |
II |
Safety & efficacy |
76 hypercholesterolemic patients |
733-001, 733-003 & 733-006
Combination with ezetimibe or atorvastitn |
II |
Safety & efficacy |
286 hypercholesterolemic patients |
733-004
Hepatic imaging study in combo with atorvastatin, fenofibrate or ezetimibe |
II |
Efficacy & hepatic lipid accumulation |
260 hypercholesterolemic patients |
733-012
Pivotal, ascending dose titration |
III |
Efficacy & long-term safety |
29 HoFH patients |
Advocacy, Education and Support Groups in Lipid Diseases
- Lipids Online - Educational Resources in Artherosclerosis - the online resource for clinicians, researchers and educators with an interest in atherosclerosis, dyslipidemia and lipid management.
- CVSpectrum.org - Information and Education across the Spectrum of Cardiometabolic Diseases
- National Lipid Association - Enhancing the practice of lipid management in clinical medicine
- MEDPED (Make Early Diagnosis to Prevent Early Deaths) - Identifying, diagnosing and promoting treatment of persons with inherited high cholesterol and their affected relatives.
- National Cholesterol Education Program - Provides educational efforts directed at health professionals and the public to raise awareness and understanding about high blood cholesterol as a risk factor for Coronary Heart Disease (CHD) and the benefits of lowering cholesterol levels as a means of preventing CHD.
- Learn Your Lipids - Patient Information from the Foundation of the National Lipid Association
- American Heart Association - National directory of resources related to heart disease
- American College of Cardiology - The American College of Cardiology is transforming cardiovascular care and improving heart health.
- European Atherosclerosis Society - The European Atherosclerosis organizes events, such as Congresses, Courses and Workshops, and through its journal Atherosclerosis, the EAS affords medical professionals access to the latest knowledge in CV areas.
- European Society of Cardiology - The European Society of Cardiology’s mission is to reduce the burden of cardiovascular disease in Europe.
- International Atherosclerosis Society - The International Atherosclerosis Society (IAS), incorporated in 1979, promotes, at an international level, the advancement of science, research and teaching in the field of atherosclerosis and related diseases.
- CCMDweb.org - An educational resource on global risk reduction - links to helpful guides and facts about various cardiovascular conditions.
- National Organization for Rare Diseases (NORD) - NORD is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and service. NORD has a special section with information about familial hypersholeserolemia.
- Genetic and Rare Diseases (GARD) Information Center - a collaborative effort of two agencies of the National Institutes of Health, The Office of Rare Diseases Research (ORDR) and the National Human Genome Research Institute (NHGRI) to help people find useful information about genetic conditions and rare diseases.
- Rare Disease Search Engine - specialized search engine using Google's co-op program combined with a narrowed field of search
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