Clinical trials: Lipid Metabolism Disorders
Hyperlipidemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0167 in Healthy Participants
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAL0167 following single and multiple dose administration in healthy participants.
- Trial name
- NCT07722299
- Testing
- SAL0167 group
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Hypercholesterolemia, LDL Cholesterol
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
- Trial name
- NCT01859455
- Testing
- LGT209 50 mg, LGT209 300 mg, Statins (atorvastatin or simvastatin)
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Non-Insulin-Dependent, Hypertriglyceridemia
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and…
- Trial name
- NCT02113163
- Testing
- Metformin Eicosapentaenoate, Metformin HCl and Vascepa
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Thetis Pharmaceuticals LLC
Hypercholesterolaemia
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
Primary Objectives: To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with…
- Trial name
- NCT02585778
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
- Where
- 110 sites in United States, Austria and 8 more
- Volunteers
- 517 people
- Sponsor
- Sanofi
Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Trial name
- VICTORION-LEAP (NCT07543731)
- Where
- Switzerland
- Volunteers
- 5,995 people
- Sponsor
- Novartis Pharmaceuticals
Gaucher Disease
Lentiviral Vector Gene Therapy - The Guard1 Trial of AVR-RD-02 for Subjects With Type 1 Gaucher Disease
This was a multinational, open-label study to assess the safety and efficacy of AVR-RD-02 in approximately 8 to 16 subjects (male or female) who are ≥18 and ≤50 years of age and post pubertal at Screening with a confirmed…
- Trial name
- NCT04145037
- Testing
- AVR-RD-02
- Where
- 5 sites in United States, Canada
- Volunteers
- 8 people
- Sponsor
- AVROBIO
Healthy
CKD-391 Pharmacokinetic Study Phase I
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
- Trial name
- NCT02501200
- Testing
- CKD-391, Atrovastatin and Ezetimibe combination therapy
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Hypertriglyceridemia
The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects
The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.
- Trial name
- NCT01486433
- Testing
- Simvastatin, acetylsalicylic acid (ASA), omefas
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hypercholesterolemia and Hyperlipidemia
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration.
- Trial name
- NCT06837077
- Testing
- SHR-1209 single-site subcutaneous injection, SHR-1209 multiple-site subcutaneous injections
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hypertriglyceridemia
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers.
- Trial name
- NCT00688857
- Testing
- Diazoxide choline
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Essentialis, Inc.
Gaucher's Disease
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ
Primary Objective To evaluate the efficacy on hematologic manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ To evaluate the safety profile of imiglucerase in maximum dose in…
- Trial name
- SEED (NCT04656600)
- Testing
- Cerezyme® / Imiglucerase
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Sanofi
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease…
- Trial name
- NCT01516541
- Testing
- Background care, dalcetrapib
- Where
- 241 sites in United States, Australia and 11 more
- Volunteers
- 2,220 people
- Sponsor
- Hoffmann-La Roche
Hypercholesterolemia, Hypertriglyceridemia
Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia
This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in…
- Trial name
- Lipiback (NCT02989753)
- Testing
- VAL070-A, VAL070-B
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Dyslipidemia
Study of A3309 in Patients With Dyslipidemia
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).
- Trial name
- NCT01069783
- Testing
- A3309
- Where
- Sweden
- Volunteers
- 36 people
- Sponsor
- Albireo
Dyslipidemia
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
- Trial name
- NCT01301066
- Testing
- Pitavastatin, Pravastatin
- Where
- 35 sites in United States
- Volunteers
- 252 people
- Sponsor
- Kowa Research Institute, Inc.
Hypercholesterolemia
The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.
- Trial name
- NCT00405067
- Testing
- BMS-201038 (AEGR-733), Ezetimibe
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Niemann-Pick Disease, Niemann-Pick Disease, Type C
Biomarker for Niemann Pick Type C Disease (BioNPC)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Niemann Pick Type C disease from Blood (plasma)
- Trial name
- BioNPC (NCT01306604)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Hypertension, Hyperlipidemia
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.
- Trial name
- NCT02994745
- Testing
- Fimasartan, Atorvastatin
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Homozygous Familial Hypercholesterolemia
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).
- Trial name
- NCT03455777
- Testing
- AKCEA-ANGPTL3-LRX
- Where
- Canada
- Sponsor
- Akcea Therapeutics
Hypertriglyceridemia
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with…
- Trial name
- COMBOS (NCT00246701)
- Testing
- Simvastatin, Simvastatin + Lovaza
- Volunteers
- 256 people
- Sponsor
- GlaxoSmithKline
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