Clinical trials: Lipid Metabolism
Gaucher Disease
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the…
- Trial name
- NCT00705939
- Testing
- Taliglucerase alfa
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 45 people
- Sponsor
- Pfizer
Homozygous Familial Hypercholesterolemia
Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)
Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks.
- Trial name
- Gateway (NCT05217667)
- Testing
- ARO-ANG 3 Injection
- Where
- 7 sites in United States, Australia and 2 more
- Volunteers
- 18 people
- Sponsor
- Arrowhead Pharmaceuticals
Hypercholesterolemia
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol.
- Trial name
- NCT00101439
- Testing
- ezetimibe
- Volunteers
- 58 people
- Sponsor
- Organon and Co
Dyslipidemia
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
- Trial name
- NCT00664859
- Testing
- LCP-AtorFen
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Veloxis Pharmaceuticals
Barth Syndrome
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.
- Trial name
- TAZPOWER (NCT03098797)
- Testing
- Elamipretide
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stealth BioTherapeutics Inc.
Primary Hypercholesterolemia, Mixed Dyslipidemia
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets…
- Trial name
- NCT01335997
- Testing
- ER niacin/laropiprant (ERN/LRPT), ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM), Simvastatin (SIM)
- Volunteers
- 1,139 people
- Sponsor
- Merck Sharp & Dohme LLC
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial…
- Conditions
- Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia, Diabetes
- Trial name
- ORION-1 (NCT02597127)
- Testing
- ALN-PCSSC, Normal Saline
- Where
- 54 sites in United States, Canada and 3 more
- Volunteers
- 501 people
- Sponsor
- The Medicines Company
Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated…
- Conditions
- Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
- Trial name
- ORION-3 (NCT03060577)
- Testing
- Inclisiran, Evolocumab
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Mixed Dyslipidemia, Coronary Heart Disease
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the…
- Conditions
- Mixed Dyslipidemia, Coronary Heart Disease, Dyslipidemia
- Trial name
- NCT00300469
- Testing
- ABT-335, Atorvastatin
- Where
- United States
- Volunteers
- 613 people
- Sponsor
- Abbott
Fabry Disease
Safety Study of Replagal® Therapy in Children With Fabry Disease
The purpose of this study is to assess the safety of Replagal in children with Fabry disease who who have not previously been treated with enzyme replacement therapy (ERT).
- Trial name
- NCT01363492
- Testing
- Replagal (agalsidase alfa)
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Shire
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Hypercholesterolemia
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is…
- Trial name
- NCT02741245
- Testing
- Ezetimibe 10 mg, Rosuvastatin 2.5 mg
- Volunteers
- 321 people
- Sponsor
- Organon and Co
Type II Diabetes Mellitus, Dyslipidemia
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.
- Trial name
- NCT00344370
- Testing
- Pitavastatin, Atorvastatin
- Where
- 35 sites in Denmark, Germany and 4 more
- Volunteers
- 214 people
- Sponsor
- Kowa Research Europe
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Trial name
- NCT01644175
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 76 sites in United States
- Volunteers
- 316 people
- Sponsor
- Sanofi
Hypertension, Hypercholesterolemia
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
- Trial name
- NCT00530946
- Testing
- Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg, Amlodipine 5mg/Atorvastatin 5mg
- Where
- 17 sites in Japan
- Volunteers
- 165 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Metabolic Syndrome
The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome
- Trial name
- NCT00664742
- Testing
- Fluvastatin XL®
- Where
- Turkey (Türkiye)
- Volunteers
- 614 people
- Sponsor
- Novartis
Hypercholesterolemia, Dyslipidemias
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
- Trial name
- NCT00330876
- Testing
- Pitavastatin
- Where
- 59 sites in Denmark, Germany and 3 more
- Volunteers
- 545 people
- Sponsor
- Kowa Research Europe
Dyslipidaemias, Dyslipidemias
Study to Test GSK256073 in Patients With Dyslipidemia
This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part…
- Trial name
- NCT00903617
- Testing
- GSK256073, Niaspan
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
Gaucher Disease
Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease
The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per kilogram [U/kg] every other week [EOW]) in treatment-naive participants with type 1 Gaucher disease on change from baseline in lumbar…
- Trial name
- NCT02574286
- Testing
- Velaglucerase alfa, Vitamin D
- Where
- 15 sites in United States, Israel and 2 more
- Volunteers
- 21 people
- Sponsor
- Shire
ASCVD, Elevated Cholesterol
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability…
- Trial name
- ORION-10 (NCT03399370)
- Testing
- Inclisiran Sodium
- Where
- 145 sites in United States
- Volunteers
- 1,561 people
- Sponsor
- The Medicines Company