NCT05255458

A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia

A Phase 3 Clinical Study Evaluating the Long-term Efficacy and Safety of AK102 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Detailed description

This is a Phase 3 clinical study to evaluate the long-term efficacy and safety of AK102, a monoclonal antibody, against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
BIOLOGICAL	AK102	Administered AK102 by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
DRUG	Placebo	Administered placebo by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies

Timeline

• Start date: 2021-11-04
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2022-02-24
• Last updated: 2025-02-28

Locations

1 site across 1 country: China