Clinical trials: Lipid Disorders
Hypercholesterolemia
Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
Primary Objective: To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
- Trial name
- NCT01448317
- Testing
- Alirocumab (Solution), Alirocumab (Lyophilized formulation)
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Subjects
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm).
- Trial name
- NCT02279485
- Testing
- Perampanel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Dyslipidemia
A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.
- Trial name
- NCT00847197
- Testing
- MK1903
- Volunteers
- 191 people
- Sponsor
- Merck Sharp & Dohme LLC
Dyslipidemias
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWX205
This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia). Researchers will check if a single dose of MWX205 is safe and how the body reacts to it.
- Trial name
- NCT07634510
- Testing
- MWX205
- Volunteers
- 37 people
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
Prediabetic State, Diabetes type2
Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)
This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects.
- Conditions
- Prediabetic State, Diabetes type2, Dysglycemia
- Trial name
- REVERSE-IT (NCT04423302)
- Testing
- TOTUM-63 3 intakes per day, TOTUM-63 2 intakes per day
- Where
- 52 sites in Bulgaria, France and 5 more
- Volunteers
- 636 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Diabetes Mellitus
Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.
- Trial name
- NCT00286442
- Testing
- Alogliptin and metformin, Metformin
- Where
- 56 sites in United States, Argentina and 15 more
- Volunteers
- 527 people
- Sponsor
- Takeda
Metabolic Health
Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions
US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms.
- Trial name
- NCT05564273
- Testing
- VIOME Precision Nutrition Program, VIOME-designed condition-based supplements
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Viome
Sub-healthy, Hyperlipidemia
The Exploratory Study About the Effect of Using Double Filtration Plasmapheresis (DFPP) Removing Inflammatory Cytokines, Lipids and Toxic Metal Ions in Peripheral Blood in Adults
This study investigates whether using Double Filtration Plasmapheresis (DFPP) could improve the overall health of adults through removing inflammatory cytokines, lipids and toxic metal ions from peripheral blood.
- Conditions
- Sub-healthy, Hyperlipidemia, Toxic Metal Ions Accumulation
- Trial name
- NCT06224296
- Testing
- DFPP
- Where
- China
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
Elevated LDL Cholesterol
Oat and Cholesterol
The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo.
- Trial name
- NCT03911427
- Testing
- Active oat beverage, Control rice beverage
- Where
- Canada
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
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.
Acid Sphingomyelinase Deficiency, Niemann-Pick Disease
Safety Study of rhASM Enzyme Replacement Therapy in Adults With Acid Sphingomyelinase Deficiency (Niemann-Pick Disease)
The purpose of this study is to determine the safe range of single doses of rhASM administered to adults with ASM deficiency.
- Trial name
- NCT00410566
- Testing
- rhASM
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Hypercholesterolemia
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that…
- Trial name
- ACT II (NCT01381679)
- Testing
- Ezetimibe
- Volunteers
- 1,682 people
- Sponsor
- Organon and Co
Healthy
A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers. Primary Objectives: 1.
- Trial name
- NCT00776841
- Testing
- Aramchol
- Where
- Israel
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Galmed Medical Reserch
Hypertriglyceridemia
A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in adults with moderate hypertriglyceridemia and diabetic kidney disease.
- Trial name
- NCT07848880
- Testing
- DR10624 Injection
- Where
- 2 sites in China
- Volunteers
- 315 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
Severe Hypertriglyceridemia
Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly [QW] or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in…
- Trial name
- NCT04541186
- Testing
- Pegozafermin
- Where
- 48 sites in United States, Czechia and 2 more
- Volunteers
- 86 people
- Sponsor
- 89bio, Inc.
Elevated LDL-Cholesterol (LDL-C)
Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol (LDL-C).
- Trial name
- NCT01437059
- Testing
- ALN-PCS02, Sterile Normal Saline (0.9% NaCl)
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Dyslipidaemia
CEntralized Pan-Russian Survey of tHE Undertreatment of hypercholeSterolemia II (CEPHEUS II)
This is a multi-center survey of patients who are currently receiving lipid-lowering medications and have a moderate or higher cardiovascular (CV) risk. The survey will be conducted in the Russian Federation.
- Trial name
- CEPHEUSII (NCT02230241)
- Where
- 27 sites in Russia
- Volunteers
- 2,700 people
- Sponsor
- AstraZeneca
Dyslipidemias
A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step…
- Trial name
- NCT00644670
- Testing
- Atorvastatin
- Where
- 17 sites in Belgium
- Volunteers
- 232 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia
Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients with hypercholesterolemia.
- Trial name
- NCT03479983
- Testing
- AMX160
- Where
- Armenia
- Volunteers
- 132 people
- Sponsor
- Arjuna Natural Limited
Homozygous Familial Hypercholesterolemia
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- ORION-5 (NCT03851705)
- Testing
- Inclisiran Sodium for injection
- Where
- 13 sites in Hong Kong, Israel and 6 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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