Clinical trials: Lipids Metabolism
Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
- Trial name
- NCT00837824
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company
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
Dyslipidemia
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic…
- Trial name
- NCT00441480
- Testing
- Plant sterols esters
- Where
- Israel
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Dyslipidemias, High Cholesterol
Randomized Study of Obicetrapib in Combination With Ezetimibe
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- OCEAN (NCT04770389)
- Testing
- Obicetrapib 5mg, Ezetimibe 10mg
- Where
- 9 sites in United States, Netherlands
- Volunteers
- 112 people
- Sponsor
- NewAmsterdam Pharma
Hypercholesterolemia or Combined Dyslipidemia
Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients
- Trial name
- NCT00257686
- Testing
- Pitavastatin, Pravastatin
- Where
- 62 sites in Denmark, Germany and 3 more
- Volunteers
- 962 people
- Sponsor
- Kowa Research Europe
Severe Hypertriglyceridemia
Epanova® for Lowering Very High Triglycerides
The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.
- Trial name
- EVOLVE (NCT01242527)
- Testing
- omefas
- Where
- 68 sites in United States, Denmark and 5 more
- Volunteers
- 399 people
- Sponsor
- AstraZeneca
Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in…
- Conditions
- Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia
- Trial name
- NCT05355402
- Testing
- Olezarsen
- Where
- 24 sites in United States, Canada
- Volunteers
- 154 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
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
Fabry Disease
Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease
The primary objective of this study was to compare the effect of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).
- Trial name
- NCT00925301
- Testing
- migalastat hydrochloride
- Where
- 28 sites in United States, Argentina and 11 more
- Volunteers
- 67 people
- Sponsor
- Amicus Therapeutics
Diabetes Mellitus
Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus
- Trial name
- NCT00286494
- Testing
- Alogliptin and pioglitazone, Pioglitazone
- Where
- 77 sites in United States, Argentina and 12 more
- Volunteers
- 493 people
- Sponsor
- Takeda
Homozygous Familial Hypercholesterolemia (HoFH)
A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)
This first-in-human study is intended to evaluate the safety and preliminary effectiveness of AAV (Adeno-associated virus)-based liver-directed gene therapy in the treatment of adults with Homozygous Familial Hypercholesterolemia…
- Trial name
- NCT02651675
- Testing
- AAV directed hLDLR gene therapy
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- REGENXBIO Inc.
Fabry Disease
Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
- Trial name
- NCT00526071
- Testing
- migalastat HCl
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 23 people
- Sponsor
- Amicus Therapeutics
Hypercholesterolemia, Coronary Heart Disease
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at…
- Trial name
- NCT00770146
- Testing
- Mipomersen sodium
- Where
- 62 sites in United States
- Volunteers
- 158 people
- Sponsor
- Kastle Therapeutics, LLC
Type IIa and IIb Hypercholesterolaemia
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg.
- Trial name
- CAP-Chol (NCT00631189)
- Testing
- Rosuvastatin, Pravastatin, Atorvastatin
- Where
- 170 sites in France
- Volunteers
- 668 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
- Trial name
- NCT01730040
- Testing
- Alirocumab, Atorvastatin, Ezetimibe
- Where
- 97 sites in United States, Australia and 7 more
- Volunteers
- 355 people
- Sponsor
- Regeneron Pharmaceuticals
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
Hypercholesterolemia
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese…
- Trial name
- NCT02055976
- Testing
- Bococizumab (PF-04950615;RN316), Ezetimibe
- Where
- 9 sites in Japan
- Volunteers
- 218 people
- Sponsor
- Pfizer
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
- Trial name
- NCT03067441
- Testing
- bempedoic acid
- Where
- 3 sites in United States
- Volunteers
- 1,462 people
- Sponsor
- Esperion Therapeutics, Inc.
Dyslipidemias, Lipid Metabolism Disorders
A Study of LY3561774 in Participants With Mixed Dyslipidemia
This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on…
- Conditions
- Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases, Hyperlipoproteinemia
- Trial name
- PROLONG-ANG3 (NCT05256654)
- Testing
- LY3561774
- Where
- 41 sites in United States, Argentina and 5 more
- Volunteers
- 205 people
- Sponsor
- Eli Lilly and Company
Hyperlipidemia
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
- Trial name
- SPIRE-HR (NCT01968954)
- Testing
- Bococizumab (PF-04950615;RN316)
- Where
- 103 sites in United States, Australia and 7 more
- Volunteers
- 711 people
- Sponsor
- Pfizer