Clinical trials: Metabolism, Lipids
Hypertriglyceridemia, Cardiovascular Disease
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent…
- Trial name
- ESPRIT (NCT01408303)
- Testing
- Olive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
- Where
- 89 sites in United States
- Volunteers
- 646 people
- Sponsor
- AstraZeneca
Hypercholesterolemia, Dyslipidemias
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.
- Conditions
- Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders
- Trial name
- NCT01435382
- Testing
- PF-04950615 (RN316)
- Where
- 7 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dyslipidemias, Non-Alcoholic Fatty Liver Disease
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with…
- Trial name
- NCT06007651
- Testing
- LY3885125
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Eli Lilly and Company
Obesity
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of…
- Trial name
- NCT00395135
- Testing
- Lorcaserin 10 mg BID
- Where
- United States
- Volunteers
- 3,182 people
- Sponsor
- Eisai Inc.
Dyslipidemia
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
- Trial name
- NCT00664859
- Testing
- LCP-AtorFen
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Veloxis Pharmaceuticals
ASCVD, Elevated Cholesterol
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
- Conditions
- ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
- Trial name
- ORION-8 (NCT03814187)
- Testing
- Inclisiran Sodium
- Where
- 238 sites in United States, Canada and 11 more
- Volunteers
- 3,275 people
- Sponsor
- Novartis Pharmaceuticals
Gaucher Disease
A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the…
- Trial name
- NCT00376168
- Testing
- Plant cell expressed recombinant glucocerebrosidase (prGCD)
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 32 people
- Sponsor
- Pfizer
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
- Trial name
- FOURIER OLE (NCT02867813)
- Testing
- Evolocumab
- Where
- 198 sites in United States, Czechia and 5 more
- Volunteers
- 5,035 people
- Sponsor
- Amgen
GM2 Gangliosidosis, Tay-Sachs Disease
N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)
This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff…
- Conditions
- GM2 Gangliosidosis, Tay-Sachs Disease, Sandhoff Disease
- Trial name
- NCT03759665
- Testing
- IB1001
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- IntraBio Inc
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- ODYSSEY MONO (NCT01644474)
- Testing
- Alirocumab, Ezetimibe
- Where
- 8 sites in United States, Belgium and 2 more
- Volunteers
- 103 people
- Sponsor
- Sanofi
Obesity, Obesity, Abdominal
Vestibular Stimulation to Trigger Adipose Loss Clinical Trial
There is an ongoing and worsening problem with obesity in the developed, and much of the developing world. Although it has long been realized that Western diets that are rich in sugar and fat play an important role in this, it…
- Conditions
- Obesity, Obesity, Abdominal, Metabolic Syndrome, Weight Loss
- Trial name
- VeSTAL (NCT03138369)
- Testing
- Vestibular nerve stimulator
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Neurovalens Ltd.
Type II Diabetes Mellitus, Dyslipidemia
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.
- Trial name
- NCT00344370
- Testing
- Pitavastatin, Atorvastatin
- Where
- 35 sites in Denmark, Germany and 4 more
- Volunteers
- 214 people
- Sponsor
- Kowa Research Europe
Gaucher Disease, Type 1
Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular…
- Trial name
- NCT00553631
- Testing
- velaglucerase alfa, imiglucerase
- Where
- 11 sites in United States, Argentina and 7 more
- Volunteers
- 34 people
- Sponsor
- Shire
Hypercholesterolemia, Familial Hypercholesterolemia
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with…
- Trial name
- NCT02748057
- Testing
- Ezetimibe, Rosuvastatin
- Volunteers
- 135 people
- Sponsor
- Organon and Co
Hypercholesterolemia
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with…
- Trial name
- NCT01154036
- Testing
- ezetimibe 10 mg, atorvastatin, Comparator: rosuvastatin
- Volunteers
- 1,547 people
- Sponsor
- Organon and Co
Type 2 Diabetes Mellitus, Hypercholesterolemia
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects.
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes
- Trial name
- NCT00570739
- Testing
- Metformin HCl tablets and Colesevelam tablets, Colesevelam
- Where
- 31 sites in United States, Colombia and 2 more
- Volunteers
- 502 people
- Sponsor
- Daiichi Sankyo
Hypercholesterolemia
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10 mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with…
- Trial name
- NCT02550288
- Testing
- Ezetimibe 10 mg, Atorvastatin 10 mg, Diet control/Daily Exercise
- Volunteers
- 309 people
- Sponsor
- Organon and Co
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
Hypercholesterolemia, Dyslipidemia
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
- Trial name
- NCT01350141
- Testing
- PF-04950615 (RN316)
- Where
- 35 sites in United States, Canada
- Volunteers
- 46 people
- Sponsor
- Pfizer
Homozygous Familial Hypercholesterolaemia (HoFH)
Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)
This is a single arm, open label, multi centre phase III study to evaluate the efficacy and long term safety of lomitapide in paediatric patients with HoFH receiving stable lipid lowering therapy (LLT) (including lipoprotein…
- Trial name
- NCT04681170
- Testing
- Lomitapide
- Where
- 12 sites in Germany, Israel and 4 more
- Volunteers
- 46 people
- Sponsor
- Amryt Pharma