Clinical trials: Lipoprotein Disorder
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM)…
- Trial name
- NCT02833844
- Testing
- Evolocumab
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 467 people
- Sponsor
- Amgen
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Elevated LDL Cholesterol
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of…
- Trial name
- NCT01004705
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),, Simvastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Ferrer Internacional S.A.
Cardiovascular Disease
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
- Trial name
- NCT04270760
- Testing
- Olpasiran
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 281 people
- Sponsor
- Amgen
Hypercholesterolemia, Heterozygous Familial
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein…
- Trial name
- FOCUS FH (NCT01475825)
- Testing
- mipomersen sodium 200 mg, mipomersen sodium 70 mg
- Where
- 113 sites in United States, Argentina and 28 more
- Volunteers
- 309 people
- Sponsor
- Kastle Therapeutics, LLC
Hypercholesterolemia
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use…
- Trial name
- FUTURA (NCT00526058)
- Testing
- Secura then Futura, Futura then Secura
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- B. Braun Medical Inc.
Nonalcoholic Steatohepatitis
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on…
- Trial name
- CONTROL (NCT02633956)
- Testing
- Obeticholic Acid, Atorvastatin
- Where
- 22 sites in United States
- Volunteers
- 84 people
- Sponsor
- Intercept Pharmaceuticals
Lipoprotein Disorder
A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.
- Trial name
- NCT05565742
- Testing
- LY3819469
- Where
- 80 sites in United States, Argentina and 8 more
- Volunteers
- 320 people
- Sponsor
- Eli Lilly and Company
Dyslipidemia
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia.
- Trial name
- PURSUIT (NCT06173570)
- Testing
- AZD0780
- Where
- 55 sites in United States, Canada and 6 more
- Volunteers
- 428 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
Cardiovascular Disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)].
- Trial name
- NCT03626662
- Testing
- AMG 890
- Where
- 9 sites in United States, Australia
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Amgen
ASCVD, Risk Factor, Cardiovascular
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy…
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Trial name
- ORION-11 (NCT03400800)
- Testing
- Inclisiran Sodium
- Where
- 70 sites in Czechia, Germany and 5 more
- Volunteers
- 1,617 people
- Sponsor
- The Medicines Company
Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of triglyceride (TG) levels in participants with FCS.
- Conditions
- Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
- Trial name
- NCT03360747
- Testing
- AKCEA-ANGPTL3-LRx
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Akcea Therapeutics
Hypercholesterolemia
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to…
- Trial name
- NCT02476006
- Testing
- ALIROCUMAB SAR236553 (REGN727), ezetimibe, atorvastatin
- Where
- 153 sites in Austria, Belgium and 14 more
- Volunteers
- 998 people
- Sponsor
- Sanofi
Type 2 Diabetes
A Diabetes Study to Treat A Population Previously Not at Target
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step…
- Trial name
- ADAPT (NCT00747149)
- Testing
- Rosuvastatin
- Where
- 84 sites in Canada
- Volunteers
- 598 people
- Sponsor
- AstraZeneca
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Dyslipidemia, Cardiovascular Diseases
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete.
- Conditions
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Trial name
- SANTORINI (NCT04271280)
- Testing
- Non-interventional
- Where
- 540 sites in Austria, Belgium and 12 more
- Volunteers
- 9,559 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Dyslipidemia, Hypercholesterolemia
A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be…
- Trial name
- NCT01333436
- Testing
- Test Meal
- Where
- South Korea
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Primary Hypercholesterolemia, Dyslipidemia
A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
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
- NCT01294683
- Testing
- Simvastatin, Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM), Extended Release (ER) niacin/laropiprant (N/LRPT)
- Volunteers
- 977 people
- Sponsor
- Merck Sharp & Dohme LLC