Clinical trials: PCSK9 Inhibitor
Hypercholesterolemia
A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health Subjects
JS002 is a recombinant humanized Anti- PCSK9 monoclonal antibody; This is a phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single…
- Trial name
- NCT04197817
- Testing
- JS002
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
HIV Seropositivity, Dyslipidemias
COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients
Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.
- Conditions
- HIV Seropositivity, Dyslipidemias, PCSK9
- Trial name
- COPANA (NCT03139630)
- Where
- France
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Franck Boccara
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
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.
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
Efficacy and Safety, Heterozygous Familial Hypercholesterolemia
Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia
This study plans to enroll several patients with heterozygous familial hypercholesterolemia, randomly assigned to different dose groups, and randomly receiving subcutaneous injection of IBI306150 mg or placebo every two weeks: or…
- Conditions
- Efficacy and Safety, Heterozygous Familial Hypercholesterolemia, PCSK9
- Trial name
- NCT04759534
- Testing
- protein convertase subtilisin/kexin type 9 inhibitor
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Atherosclerosis, Cardiovascular Diseases
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
The INTENSITY-LOW study aims to answer if there are any limits to LDL reduction in relation to benefitting vascular health from a mechanistic viewpoint, and therefore potentially limitations to primary prevention in healthy…
- Trial name
- NCT03273972
- Testing
- Written Informed Consent, Inclusion/Exclusion check, Full Clinical Chemistry and Haematology Bloods
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
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