Clinical trials: Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH
The purpose is to study Safety and Tolerability.
- Trial name
- NCT01350960
- Testing
- SPC5001, Saline 0.9%
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Santaris Pharma A/S
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
This was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the United States.
- Trial name
- NCT07023445
- Where
- United States
- Volunteers
- 37,688 people
- Sponsor
- Novartis Pharmaceuticals
Homozygous Familial Hypercholesterolemia
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT06009393
- Testing
- SHR-1918
- Where
- China
- Volunteers
- 26 people
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
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
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00694109
- Testing
- Mipomersen Sodium
- Where
- 33 sites in United States, Brazil and 5 more
- Volunteers
- 144 people
- Sponsor
- Kastle Therapeutics, LLC
Subjects With Hyperlipidemia, Dyslipidemia
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).
- Trial name
- ANITSCHKOW (NCT02729025)
- Testing
- Evolocumab
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 129 people
- Sponsor
- Amgen
Diagnosed With HoFH
Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Homozygous Familial Hypercholesterolemia
This trial is a multicenter, open-label, phase II clinical study, aiming to evaluate the efficacy and safety of SYH2070 injection in participants with HoFH.
- Trial name
- NCT07591298
- Testing
- SYH2070 injection dose1, SYH2070 injection dose2
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Cardiovascular, Metabolic Disease
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.
- Conditions
- Cardiovascular, Metabolic Disease, Dyslipidemias, Lipid Disorder
- Trial name
- NCT07491172
- Testing
- CTX310
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- CRISPR Therapeutics AG
Homozygous Familial Hypercholesterolemia
Study to Evaluate the Effects of MBX-8025 in Patients With HoFH
A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).
- Trial name
- NCT02472535
- Testing
- MBX-8025 50 mg (Dose Escalation Period 1), MBX-8025 50 mg or 100 mg (Dose Escalation Period 2), MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3)
- Where
- 5 sites in Canada, France and 2 more
- Volunteers
- 13 people
- Sponsor
- Gilead Sciences
Hypercholesterolemia, Dyslipidemias
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W [≤31 days]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic…
- Conditions
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT06568471
- Testing
- Lerodalcibep
- Where
- 18 sites in China
- Volunteers
- 210 people
- Sponsor
- Hasten Biopharmaceutical Co., Ltd.
Heterozygous Familial Hypercholesterolemia, Premature Coronary Heart Disease
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease…
- Trial name
- NCT06164730
- Testing
- VERVE-102
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 85 people
- Sponsor
- Verve Therapeutics, Inc.
Hypercholesterolemia, Familial, Hyperlipidemia
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial…
- Trial name
- NCT00134485
- Testing
- torcetrapib/atorvastatin, atorvastatin
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
Severe Familial Hypercholesterolemia
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
- Trial name
- TAUSSIG (NCT01624142)
- Testing
- Evolocumab
- Where
- 44 sites in United States, Australia and 16 more
- Volunteers
- 300 people
- Sponsor
- Amgen
Heterozygous Familial Hypercholesterolemia
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with…
- Trial name
- LIBerate-FH (NCT04797104)
- Testing
- lerodalcibep
- Where
- 7 sites in United States, Israel and 3 more
- Volunteers
- 478 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolaemia
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years…
- Trial name
- ODYSSEY KIDS (NCT02890992)
- Testing
- alirocumab SAR236553 (REGN727), statins, ezetimibe
- Where
- 16 sites in United States, Canada and 8 more
- Volunteers
- 42 people
- Sponsor
- Sanofi
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Homozygous Familial Hypercholesterolemia
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).
- Trial name
- NCT03455777
- Testing
- AKCEA-ANGPTL3-LRX
- Where
- Canada
- Sponsor
- Akcea Therapeutics
Familial Hypercholesterolemia
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia.
- Trial name
- NCT04455581
- Testing
- SHR-1209
- Volunteers
- 8 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
Familial Hypercholesterolemia
Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients…
- Trial name
- NCT00079846
- Testing
- Implitapide
- Where
- 6 sites in United States, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Medical Research Laboratories International