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A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

NCT04173793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

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 heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.

Conditions

  • Heterozygous Familial Hypercholesterolemia

Interventions

DRUG

AK102

Administered by subcutaneous injection

DRUG

Placebo

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

  • Shuyang Zhang, MD · Peking Union Medical College Hospital

  • Yujie Zhou, MD · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2022-09-26
Completion
2022-09-26

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04173793 on ClinicalTrials.gov