Clinical trials: PCSK9
Hypercholesterolemia
Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects
Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel group, phase I clinical trial of repeated administration by subcutaneous injection of a single dose of one of two different proprotein…
- Trial name
- AFF012 (NCT02508896)
- Testing
- AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant, Adjuvant without active component
- Where
- Austria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Affiris AG
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
Primary Hyperlipidemia and Mixed Dyslipidemia
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
- Trial name
- FLOREY (NCT02189837)
- Testing
- Evolocumab, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Amgen
Atherosclerosis
An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels
- Trial name
- NCT00847782
- Testing
- Blood draw
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hypercholesterolemia, LDL Cholesterol
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
- Trial name
- NCT01859455
- Testing
- LGT209 50 mg, LGT209 300 mg, Statins (atorvastatin or simvastatin)
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Moderate Renal Impairment
A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)
This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants.
- Trial name
- NCT05070390
- Testing
- Enlicitide Chloride
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R…
- Trial name
- NCT03366688
- Testing
- IBI306
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hypercholesterolemia
Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia
This study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol
- Trial name
- NCT01979601
- Testing
- LGT209
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment…
- Trial name
- NCT05934292
- Testing
- Enlicitide Decanoate
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
End Stage Renal Disease
To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants.
The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and…
- Trial name
- NCT05065463
- Testing
- AZD8233
- Where
- Poland
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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