NCT04173403

A Long-term Study of AK102 in Patients With Hypercholesterolemia

A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 796 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	450mg AK102	AK102 Q4W
DRUG	300mg AK102	AK102 Q4W
DRUG	150mg AK102	AK102 Q2W
DRUG	Statins and/or Ezetimibe	Lipid-lowering therapies

Timeline

• Start date: 2019-11-04
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2019-11-22
• Last updated: 2023-03-02

Locations

1 site across 1 country: China