Clinical trials: Lipoprotein Metabolism Disorder
Hypertriglyceridemia
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins.
- Trial name
- ELLF (NCT00959842)
- Testing
- Lovaza
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Sanford Research
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
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
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
Cardiovascular Risk Factor, Type2 Diabetes Mellitus
Orange Juice And Sugar Intervention Study
The objectives of this proposal are to address the gaps in knowledge regarding the metabolic effects of consuming orange juice, the most frequently consumed fruit juice in this country, compared to sugar-sweetened beverage.
- Conditions
- Cardiovascular Risk Factor, Type2 Diabetes Mellitus, Insulin Sensitivity, Metabolic Syndrome
- Trial name
- OASIS (NCT03527277)
- Testing
- Naturally-sweetened orange juice, Sugar-sweetened beverage
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
HIV Infections, Dyslipidemias
Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)
This is a phase 2, randomized, double-blinded, placebo-controlled clinical trial. The intervention drug will be efprezimod alfa (intravenous [IV] infusion).
- Trial name
- CALIBER (NCT03960541)
- Testing
- Efprezimod alfa (human CD24 extracellular domain and human IgG1 Fc fusion protein), Saline Solution
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran.
- Trial name
- ORION-9 (NCT03397121)
- Testing
- Inclisiran
- Where
- 45 sites in United States, Canada and 6 more
- Volunteers
- 482 people
- Sponsor
- The Medicines Company
Primary Hypercholesterolemia
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.
- Trial name
- NCT00746811
- Testing
- P-OM3
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Provident Clinical Research
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
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
Obesity, Insulin Resistance
Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels
Approximately 20 million people in the United States have some form of kidney failure. People with kidney failure have an increased chance of having low levels of high density lipid (HDL), so called "good cholesterol." Patients…
- Trial name
- NCT02755818
- Testing
- Heparin
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Metabolic Syndrome
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
- Trial name
- NCT02670382
- Testing
- EPA, DHA, sunflower oil
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tufts University
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
Hypercholesterolemia, Familial
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial…
- Trial name
- RUTHERFORD (NCT01375751)
- Testing
- Evolocumab
- Volunteers
- 168 people
- Sponsor
- Amgen
Polycystic Ovary Syndrome (PCOS), Obstructive Sleep Apnea
Sex Steroids, Sleep, and Metabolic Dysfunction in Women
Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease.
- Conditions
- Polycystic Ovary Syndrome (PCOS), Obstructive Sleep Apnea, Obesity
- Trial name
- SCOR (NCT00805207)
- Testing
- Progesterone, testosterone, glucocorticoid
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Hyperlipidemia
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a…
- Trial name
- LAPLACE (NCT01380730)
- Testing
- Evolocumab
- Where
- 100 sites in United States, Canada and 3 more
- Volunteers
- 631 people
- Sponsor
- Amgen
Lipoprotein Disorder
A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.
- Trial name
- KRAKEN (NCT05563246)
- Testing
- LY3473329
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 233 people
- Sponsor
- Eli Lilly and Company
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
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.