Clinical trials: Lipid Disorders
Hypercholesterolaemia
Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07170852
- Testing
- Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Diabetes Mellitus
Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.
The purpose of this study is to determine the efficacy of pioglitazone compared to glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in type 2 diabetic subjects with cardiovascular disease.
- Trial name
- SPLENDOR (NCT00770835)
- Testing
- Pioglitazone and Metformin, Glibenclamide and Metformin
- Where
- 2 sites in Italy
- Volunteers
- 39 people
- Sponsor
- Takeda
HIV-associated Lipodystrophy Syndrome
An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects
This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to investigate the recovery, excretion, and…
- Trial name
- NCT01848340
- Testing
- GSK1265744B (sodium salt) containing 14C-GSK1265744B, 150 mg GSK1265744B
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Gaucher Disease, Type 1
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
- Trial name
- ENCORE (NCT00943111)
- Testing
- Eliglustat tartrate, Imiglucerase
- Where
- 34 sites in United States, Argentina and 10 more
- Volunteers
- 160 people
- Sponsor
- Genzyme, a Sanofi Company
Hypercholesterolemia
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R…
- Trial name
- NCT04289285
- Testing
- IBI306 450mg SC Q4W, IBI306 600mg SC Q6W
- Where
- China
- Volunteers
- 804 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy Participants, Hyperlipidemia
A Phase 1 Study of VELA-101 in Adult Participants
This is a first-in-human (FIH), multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VELA-101, following single-ascending doses…
- Trial name
- NCT07864311
- Testing
- VELA-101
- Where
- 2 sites in Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ursa Medicines
Hypercholesterolemia
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
- Trial name
- NCT00652444
- Testing
- ezetimibe, simvastatin
- Volunteers
- 120 people
- Sponsor
- Organon and Co
Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of triglyceride (TG) levels in participants with FCS.
- Conditions
- Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
- Trial name
- NCT03360747
- Testing
- AKCEA-ANGPTL3-LRx
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Akcea Therapeutics
Carcinoma, Non-Small Cell Lung
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with…
- Trial name
- Acclaim-1 (NCT04486833)
- Testing
- quaratusugene ozeplasmid, osimertinib, Platinum-Based Chemotherapy
- Where
- 10 sites in United States
- Volunteers
- 158 people
- Sponsor
- Genprex, Inc.
Fabry Disease
A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease
The main aim of the study is to assess the safety of REPLAGAL. Study participants will receive REPLAGAL as an intravenous infusion every other week for 52 weeks.
- Trial name
- NCT04974749
- Testing
- REPLAGAL
- Where
- 6 sites in China
- Volunteers
- 20 people
- Sponsor
- Takeda
Healthy Volunteers
A Study to Compare the Relative Bioavailability of Two Iberdomide (CC-220) Formulations and to Assess The Effect Of Food on the Drug Levels of Iberdomide in Healthy Adult Participants
The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the…
- Trial name
- NCT05899738
- Testing
- Iberdomide
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hyperlipidemias
Effect of ANKASCIN 568-P Products Regulating Blood Lipid
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
- Trial name
- NCT05737355
- Testing
- ANKASCIN 568-P Red yeast rice capsules
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- SunWay Biotech Co., LTD.
Hypercholesterolemia
Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients…
- Trial name
- NCT02689934
- Testing
- Lactoflorene colesterolo
- Where
- Italy
- Volunteers
- 33 people
- Sponsor
- Montefarmaco OTC SpA
GI Cancer
Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.
- Trial name
- NCT00798447
- Testing
- MLF 541, Lipofundin MCT
- Where
- 2 sites in Taiwan
- Volunteers
- 100 people
- Sponsor
- B. Braun Melsungen AG
Hypercholesterolemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels.
AZD8233 has not been evaluated in clinical studies previously. This is a first-in-human (FiH) study. This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD8233, following subcutaneous (SC) administration…
- Trial name
- NCT03593785
- Testing
- AZD8233
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Triglycerides, Weight Gain Trajectory
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
The goal of this clinical trial is to learn if drug RDX-002 works to treat high levels of fat (known as triglycerides, or TGs) in the blood in adults. It will also learn about the safety of drug RDX-002.
- Conditions
- Triglycerides, Weight Gain Trajectory, Cholesterol, Elevated
- Trial name
- NCT06640972
- Testing
- RDX-002
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Response Pharmaceuticals
Solid Tumors, Multiple Myeloma
Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple Myeloma, or Lymphoma
The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene…
- Conditions
- Solid Tumors, Multiple Myeloma, Non-Hodgkins Lymphoma, Pancreatic Neuroendocrine Tumors
- Trial name
- NCT02110563
- Testing
- DCR-MYC
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase…
- Trial name
- NCT01576484
- Testing
- Alirocumab
- Where
- 14 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- Regeneron Pharmaceuticals
Niemann-Pick Disease, Type C
Safety and Tolerability Study of VTS-270 in Pediatric Participants With Niemann-Pick Type C (NPC) Disease
This is a Phase-2, multicenter, multiple dose, open-label, 2-part evaluation study which will primarily assess the safety and tolerability of VTS-270 (2-hydroxypropyl beta-cyclodextrin [HP-β-CD]) in pediatric participants with…
- Trial name
- NCT03687476
- Testing
- VTS-270
- Sponsor
- Vtesse, LLC, a Mallinckrodt Pharmaceuticals Company
Hyperlipoproteinemia Type II, Homozygous Familial Hypercholesterolemia
Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy.
- Trial name
- NCT01841684
- Testing
- Anacetrapib
- Volunteers
- 2 people
- Sponsor
- Merck Sharp & Dohme LLC
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