Clinical trials: Cholesterol; Metabolic Disorder
Type 2 Diabetes
Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus.
- Trial name
- NCT00622089
- Testing
- DIO-902
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 150 people
- Sponsor
- DiObex
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP)…
- Trial name
- LIBerateKids (NCT07102511)
- Testing
- lerodalcibep 300 mg Monthly SC
- Where
- 7 sites in United States, Israel and 4 more
- Volunteers
- 150 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue.
- Trial name
- NCT00677248
- Testing
- Eprotirome and ezetimibe
- Where
- Sweden
- Volunteers
- 120 people
- Sponsor
- Karo Bio AB
Hypercholesterolemia
Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects
Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel group, phase I clinical trial of repeated administration by subcutaneous injection of a single dose of one of two different proprotein…
- Trial name
- AFF012 (NCT02508896)
- Testing
- AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant, Adjuvant without active component
- Where
- Austria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Affiris AG
Healthy Participants
A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.
The main purpose of this study is to assess the effect of food on balcinrenone/ dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participants.
- Trial name
- NCT06979388
- Testing
- balcinrenone/ dapagliflozin, quinidine
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to…
- Trial name
- NCT00973232
- Testing
- DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol), Zaldiar®
- Where
- United Kingdom
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Labopharm Inc.
Dyslipidemias, Hypercholesterolemia
Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- Trial name
- NCT02331043
- Testing
- Plant stanol ester
- Where
- Thailand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Raisio Group
Hypercholesterolaemia
LATAM LOWERS LDL-C
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and…
- Trial name
- NCT06501443
- Testing
- Usual care, KJX839
- Where
- 11 sites in Argentina, Brazil
- Volunteers
- 520 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis
The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).
- Trial name
- NCT01262118
- Testing
- CP-690,550 (tasocitinib)
- Where
- 11 sites in United States, Hungary
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Hypercholesterolemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in…
- Trial name
- GAUSS-4 (NCT02634580)
- Testing
- Evolocumab, Ezetimibe
- Where
- 35 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Amgen
Cholesterol Ester Storage Disease(CESD), Lysosomal Acid Lipase Deficiency
An Observational Study of Patients With Lysosomal Acid Lipase Deficiency/Cholesteryl Ester Storage Disease Phenotype
This is a Natural History study to characterize key aspects of the clinical course of late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).
- Trial name
- NCT01528917
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 49 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypercholesterolemia, Hypertriglyceridemia
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
- Trial name
- NCT00092560
- Testing
- MK0653, ezetimibe, Comparator: fenofibrate monotherapy
- Volunteers
- 587 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.
- Trial name
- NCT01600820
- Testing
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit, 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit, 3- Low fat drinkable fermented dairy product without plant sterols(control)
- Where
- Spain
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Danone Spain
Hypercholesterolaemia
Dose Effect of Limicol on (LDL)-Cholesterol Levels
The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.
- Trial name
- NCT01354340
- Testing
- Limicol
- Where
- France
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Lescuyer Laboratory
Hypercholesterolemia
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
To evaluate the effects of daily consumption of 3 capsules of Swisse Nutra+ Cholesterol Balance on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months.
- Trial name
- CLoNE (NCT04783714)
- Testing
- Swisse Nutra+ Cholesterol Balance
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Swisse Wellness Pty Ltd
Hypercholesterolemia
Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia
The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily (QD), on lowering cholesterol in subjects already taking atorvastatin.
- Trial name
- NCT00143676
- Testing
- Lapaquistat acetate and atorvastatin, Atorvastatin
- Where
- 78 sites in United States
- Volunteers
- 448 people
- Sponsor
- Takeda
Hypercholesterolemia
Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels
The goal of this study is to evaluate the hypolipidemic effect (reduction of Low Density Lipoprotein Cholesterol "LDL-C" values) of calcium-bicarbonate mineral water "Lete" (alkaline water, high in bicarbonate and calcium ions…
- Trial name
- NCT07026266
- Testing
- Water
- Where
- Italy
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Società Generale delle Acque Minerali S.p.A.
Healthy
AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects
Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the…
- Trial name
- NCT02163161
- Testing
- PF-04965842, PF- 04965842
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.