Clinical trials: Lipoprotein Metabolism Disorder
Dyslipidemias
Safety, PK, and PD of BSA204 in Chinese Adults With Borderline Elevated Lipoprotein(a)
The purpose of this Phase 1 clinical study is to evaluate the safety and tolerability of a single dose of BSA204 injection in Chinese adults with borderline high levels of lipoprotein(a) [Lp(a)].
- Trial name
- NCT07551505
- Testing
- BSA204
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bisirna Therapeutics (Suzhou) Co., Ltd.
Dyslipidemia, Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia.
- Trial name
- NCT01487460
- Testing
- TAP311
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.
The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination…
- Trial name
- NCT05787002
- Testing
- AZD0780, Rosuvastatin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hypercholesterolemia, Coronary Heart Disease
Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks
The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and…
- Trial name
- POLARIS (NCT00653588)
- Testing
- Rosuvastatin, Atorvastatin
- Sponsor
- AstraZeneca
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
Dyslipidemia
Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with low HDL
- Trial name
- NCT00689442
- Testing
- JTT-705 600 mg and atorvastatin 20 mg
- Where
- Netherlands
- Volunteers
- 105 people
- Sponsor
- Shionogi Inc.
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, Coronary Disease
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.
- Trial name
- NCT00092612
- Testing
- MK0653, ezetimibe
- Volunteers
- 372 people
- Sponsor
- Organon and Co
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Coronary Disease
Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.
- Trial name
- NCT00092599
- Testing
- MK0653, ezetimibe
- Volunteers
- 410 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Familial, Dyslipidemias
Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI
The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs.
- Conditions
- Hypercholesterolemia, Familial, Dyslipidemias, Cardiovascular Diseases
- Trial name
- DIAMOND-2018 (NCT03795038)
- Testing
- Lipoprotein Apheresis MONET and DALI, Lipoprotein Apheresis DIAMED and DALI
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Hyperlipidemia
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with…
- Trial name
- ORION-14 (NCT04774003)
- Testing
- 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran), 300 mg inclisiran sodium (equivalent to 284 mg inclisiran)
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
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
Hypercholesterolemia
STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges
To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.
- Trial name
- STELLAR (NCT00654537)
- Testing
- Rosuvastatin, Atorvastatin, Pravastatin
- Volunteers
- 5,625 people
- Sponsor
- AstraZeneca
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol
To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized…
- Trial name
- NCT06750341
- Testing
- QLC7401
- Volunteers
- 156 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesterolaemia
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood.
- Trial name
- NCT07619131
- Testing
- Laroprovstat, Rosuvastatin 1, Rosuvastatin 2
- Where
- 152 sites in United States, Bulgaria and 9 more
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Familial Hypercholesterolemia
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular…
- Trial name
- Secura (NCT00916643)
- Testing
- HELP Secura (apheresis treatment)
- Volunteers
- 113 people
- Sponsor
- B. Braun Medical Inc.
Hypercholesterolemia, Atherosclerosis
Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve…
- Trial name
- NCT00651014
- Testing
- Ezetimibe
- Volunteers
- 82 people
- Sponsor
- Organon and Co
Mixed Hyperlipoproteinemia
Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction
Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with mixed hyperlipoproteinemia.
- Trial name
- PrOteCT (NCT02069106)
- Testing
- Pro-Omega LDL
- Sponsor
- Nordic Pharma, USA