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A Long-term Study of AK102 in Patients With Hypercholesterolemia

NCT04173403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 796

Last updated 2023-03-02

No results posted yet for this study

Summary

This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.

Conditions

Interventions

DRUG

450mg AK102

AK102 Q4W

DRUG

300mg AK102

AK102 Q4W

DRUG

150mg AK102

AK102 Q2W

DRUG

Statins and/or Ezetimibe

Lipid-lowering therapies

Sponsors & Collaborators

  • AD Pharma (Guangdong)

    collaborator UNKNOWN

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Shuyang Zhang · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2023-02-17
Completion
2023-02-17

Countries

  • China

Study Locations

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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 NCT04173403 on ClinicalTrials.gov