Clinical trials: Elevated LDL-C
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
To Reduce the LDL-C Level in Hypercholesteremia Adult Patients, Combination for Subgroup High LDL-c Patients With Other Comorbidities
Adult Subjects With Elevated Low-Density Lipoprotein-Cholesterol to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects
Objectives: The primary and secondary objectives of the study are presented below. Exploratory objectives are presented in the body of the protocol.
- Trial name
- NCT05905068
- Testing
- RN0191 INJECTION
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ikaria Bioscience Pty Ltd
Hypercholesterolemia, Cardiovascular Diseases
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
Comparison of LDL-C reductions at Week 12 of monthly (Q4W[≤ 31 days]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or…
- Trial name
- LIBerate-H2H (NCT04790513)
- Testing
- lerodalcibep, evolocumab, alirocumab
- Where
- 3 sites in United States
- Volunteers
- 204 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia, Mixed Dyslipidemia
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2…
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Trial name
- BANTING (NCT02739984)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 424 people
- Sponsor
- Amgen
Healthy Volunteers
A Clinical Study for Evaluating the Safety of a Plant Sterol-enriched Fermented Dairy Product in Japanese Healthy Adults
Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults
- Trial name
- NCT02278393
- Testing
- 1-Fermented Dairy Product with Phytosterols (test), 2-Fermented dairy Product with No Phytosterols (control)
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Danone Japan
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
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
- Trial name
- NCT01849497
- Testing
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- Where
- 26 sites in United States, Canada
- Volunteers
- 149 people
- Sponsor
- Amgen
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
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
- Trial name
- NCT01879319
- Testing
- Evolocumab AMD, Evolocumab AI/pen
- Where
- 27 sites in United States, Canada
- Volunteers
- 164 people
- 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
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.
Hypercholesteremia
A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or…
- Trial name
- ROYAL-1 (NCT02634151)
- Testing
- Gemcabene
- Where
- 24 sites in United States
- Volunteers
- 105 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST 2 (NCT00442325)
- Testing
- Atorvastatin (Lipitor)
- Where
- 32 sites in Greece, Hungary and 6 more
- Volunteers
- 595 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
- Trial name
- ORION-13 (NCT04659863)
- Testing
- Inclisiran
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
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
Healthy Participants, Dyslipidemia
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a)…
- Trial name
- NCT06980428
- Testing
- AZD4954
- Where
- 6 sites in United States
- Volunteers
- 136 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal
The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol…
- Trial name
- NCT00240344
- Where
- 75 sites in Netherlands
- Volunteers
- 2,650 people
- Sponsor
- AstraZeneca
Dyslipidemias
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients
An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.
- Trial name
- RACHEL (NCT00931320)
- Volunteers
- 3,000 people
- Sponsor
- AstraZeneca
Dyslipidemias, High Cholesterol
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- ROSE (NCT04753606)
- Testing
- Obicetrapib
- Where
- 19 sites in United States
- Volunteers
- 120 people
- Sponsor
- NewAmsterdam Pharma