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A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH

NCT03933293 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-02

No results posted yet for this study

Summary

AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double blind, randomized, placebo controlled study to evaluate the efficacy and safety of PCSK9 inhibitor AK102. The treatment period will last 12 week.

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

DRUG

AK102

450mg, Q4W, subcutaneous injection

DRUG

Statins

Lipid-lowering therapies

DRUG

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

  • Lvya Wang · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2021-03-15
Completion
2021-03-15

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 NCT03933293 on ClinicalTrials.gov