Clinical trials: Metabolism, Lipids
Fabry Disease
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip infusion in participants with cardiac Fabry…
- Trial name
- NCT00140621
- Testing
- Agalsidase beta
- Where
- 7 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy Participants
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults
The purpose this study is to measure the impact of laroprovstat (AZD0780) on the pharmacokinetics (PK) of AZD4954 and the impact of AZD4954 on the PK of laroprovstat in healthy male and female participants.
- Trial name
- NCT07513571
- Testing
- AZD4954, Laroprovstat
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Lipid Metabolism, Inborn Errors, Heart Disease
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related…
- Trial name
- NCT00092898
- Testing
- MK0653, ezetimibe
- Volunteers
- 30 people
- Sponsor
- Organon and Co
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
Hyperlipidemia
A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia
This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.
- Trial name
- NCT05255458
- Testing
- AK102
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Akeso
Metachromatic Leukodystrophy (MLD)
A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy
The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to…
- Trial name
- EMBOLDEN (NCT03771898)
- Testing
- SHP611
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 36 people
- Sponsor
- Shire
Hypercholesterolemia
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability of DC371739 Treatment in Hypercholesterolemic
This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to initially explore the efficacy and safety in…
- Trial name
- NCT04927221
- Testing
- DC371739 Tablets
- Where
- China
- Volunteers
- 51 people
- Sponsor
- Guangzhou JOYO Pharma Co., Ltd
Hypercholesterolemia
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40).
- Trial name
- NCT00782184
- Testing
- ezetimibe/simvastatin 10/40, atorvastatin 40 mg, atorvastatin 20 mg
- Volunteers
- 250 people
- Sponsor
- Organon and Co
Inherited Metabolic Diseases, Lysosomal Storage Disorders
ALD-101 Adjuvant Therapy of Unrelated Umbilical Cord Blood Transfusion (UCBT) in Patients With Inherited Metabolic Diseases
Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a possible cure for their inherited metabolic disease.
- Conditions
- Inherited Metabolic Diseases, Lysosomal Storage Disorders, Peroxisomal Storage Diseases, Inborn Errors of Metabolism
- Trial name
- UCBT-002 (NCT00654433)
- Testing
- ALD-101
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Aldagen
Hypercholesterolaemia
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects.
- Trial name
- NCT04169386
- Testing
- AK102
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Akeso
Dyslipidemia, Obesity &Amp; Overweight
Improvement and Safety of Nutrilite Protein MetX Pro on Weight Management in Overweight Individuals With Dyslipidemia
The goal of this randomized, double-blind, placebo-controlled, single center study is to evaluate the impact of Nutrilite Protein MetX Pro (the study product, a high-protein compound beverages supplemented with multiple plant…
- Trial name
- NCT07094022
- Testing
- Nutrilite Protein MetX Pro
- Where
- 2 sites in China
- Volunteers
- 66 people
- Sponsor
- Amway (China) R&D Center
Hypercholesterolemia, Hyperlipidemia
Effect of MK0524A on Cholesterol Levels (0524A-048)
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
- Trial name
- NCT00536510
- Testing
- laropiprant/niacin (MK0524A)
- Volunteers
- 646 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in…
- Trial name
- NCT01288469
- Testing
- Alirocumab, Atorvastatin
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolemia
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
- Trial name
- NCT04031742
- Testing
- IBI306
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hypercholesterolemia
Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)
A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C
- Trial name
- NCT04765657
- Testing
- inclisiran sodium
- Where
- 45 sites in China, Singapore and 2 more
- Volunteers
- 345 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.
- Trial name
- NCT01286701
- Testing
- Terbinafine Hydrochloride Tablets, 250 mg
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Metachromatic Leukodystrophy
Single Patient Expanded Access Protocol: Metabolic Boost
This is a single patient expanded access protocol to investigate the effects of a second dose of facilitating cell-enhanced hematopoietic stem cell product.
- Trial name
- Boost (NCT02021266)
- Testing
- Enriched Hematopoetic Stem Cell Infusion
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Hypertriglyceridemia
Efficacy of MND-2119 in Participants With Hypertriglyceridemia
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
- Trial name
- NCT03693131
- Testing
- Icosapent (MND-2119), Icosapent (EPADEL CAPSULES 300)
- Where
- Japan
- Volunteers
- 580 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Gaucher Disease
Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease
The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per kilogram [U/kg] every other week [EOW]) in treatment-naive participants with type 1 Gaucher disease on change from baseline in lumbar…
- Trial name
- NCT02574286
- Testing
- Velaglucerase alfa, Vitamin D
- Where
- 15 sites in United States, Israel and 2 more
- Volunteers
- 21 people
- Sponsor
- Shire
Diabetes Mellitus, Type 2
Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM
To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg) versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C, TGs, TG/HDL ratio, etc), and pharmacoeconomic…
- Trial name
- NCT00289354
- Testing
- Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
- Volunteers
- 600 people
- Sponsor
- Nutrition 21, Inc.
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