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A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia

NCT04358432 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2023-03-02

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .

The primary objective of this study is to evaluate the efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .

Conditions

Interventions

DRUG

AK102

Administered by subcutaneous injection

DRUG

Placebos

Administered by subcutaneous injection

DRUG

Statins and/or Ezetimibe

Lipid-lowering therapies

Sponsors & Collaborators

  • AD Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Junbo Ge, MD · Zhong Shan Hospital Fu Dan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2021-02-25
Completion
2021-02-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358432 on ClinicalTrials.gov