Clinical trials: Hypercholesterolemia and Hyperlipidemia
Homozygous Familial Hypercholesterolemia
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
This study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to <18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and…
- Trial name
- SPRUCE (NCT07473843)
- Testing
- Zodasiran
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 10 people
- Sponsor
- Arrowhead Pharmaceuticals
Heterozygous Familial Hypercholesterolemia (HeFH)
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
A phase 1/2, two-part trial consisting of an open label dose-escalation part and a randomized, double blind, placebo-controlled part to investigate safety, tolerability, pharmacokinetics, and efficacy with EDIT-401 gene editing…
- Trial name
- NCT07894887
- Testing
- Drug: EDIT-401
- Where
- 2 sites in Australia
- Volunteers
- 56 people
- Sponsor
- Editas Medicine, Inc.
Hypercholesterolemia, Hypertriglyceridemia
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia, Refractory Hyperlipidemia
- Trial name
- NCT06451770
- Testing
- VERVE-201
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 132 people
- Sponsor
- Verve Therapeutics, Inc.
Hyperlipidemia, Hypercholesterolemia
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood. Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to…
- Trial name
- NCT07821944
- Testing
- Enlicitide Decanoate
- Where
- India
- Volunteers
- 150 people
- Sponsor
- Merck Sharp & Dohme LLC
Hyperlipidemia (E.G., Hypercholesterolemia)
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population
The goal of this clinical trial is to evaluate the efficacy and safety of a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy in the Bangladeshi population.
- Trial name
- NCT06789432
- Testing
- Atorvastatin 10 mg and ezetimibe 10 mg, Atorvastatin 20 mg
- Where
- Bangladesh
- Sponsor
- Dr. Md. Alimur Reza
Primary Prevention of Atherosclerotic Cardiovascular Disease
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at…
- Trial name
- NCT05739383
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 983 sites in United States, Argentina and 40 more
- Volunteers
- 14,012 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
- Trial name
- VICTORION-2P (NCT05030428)
- Testing
- Inclisiran sodium 300 mg
- Where
- 983 sites in United States, Argentina and 48 more
- Volunteers
- 17,004 people
- Sponsor
- Novartis Pharmaceuticals
Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed…
- Trial name
- NCT07473960
- Testing
- IBI306
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hypercholesterolemia and Hyperlipidemia
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration.
- Trial name
- NCT06837077
- Testing
- SHR-1209 single-site subcutaneous injection, SHR-1209 multiple-site subcutaneous injections
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
- Trial name
- NCT07421297
- Testing
- SYH2053 injection
- Where
- 2 sites in China
- Volunteers
- 760 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Primary Hypercholesterolemia or Mixed Hyperlipidemia
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering…
- Trial name
- NCT07441317
- Testing
- QLC7401
- Volunteers
- 780 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Primary Hypercholesterolemia or Mixed Hyperlipidemia
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy.
- Trial name
- NCT07444086
- Testing
- QLC7401
- Volunteers
- 510 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia. A total of 156 Participants were actually enrolled
- Trial name
- NCT07421232
- Testing
- Inclisiran (Leqvio®) 300mg
- Where
- China
- Volunteers
- 156 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
- Trial name
- NCT07421284
- Where
- China
- Volunteers
- 900 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Primary Hypercholesterolemia or Mixed Hyperlipidemia
A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan
Cardiovascular disease (CVD) is a chronic non-communicable disease among the most common causes of death worldwide. Substantial reductions in risks of CVD can be achieved through the management of modifiable risk factors…
- Trial name
- CLEAR Taiwan (NCT06925100)
- Testing
- Bempedoic acid 180 mg tablet
- Where
- 3 sites in Taiwan
- Volunteers
- 180 people
- Sponsor
- Daiichi Sankyo
Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination with Statin…
- Trial name
- NCT07253584
- Testing
- SAL003 140 mg
- Where
- China
- Volunteers
- 720 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Acute Coronary Syndrome
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS)…
- Trial name
- V-INCEPTION (NCT04873934)
- Testing
- Inclisiran
- Where
- 88 sites in United States
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C
Pharmacokinetics and Pharmacodynamics Study
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change.
- Trial name
- NCT07074236
- Testing
- QLC7401 injection, RBD7022 injection
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.