NCT05260411

A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia

A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (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 # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Detailed description

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, 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 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
BIOLOGICAL	AK102	Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
DRUG	Placebo	Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Timeline

• Start date: 2022-01-26
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2022-03-02
• Last updated: 2025-03-06

Locations

2 sites across 1 country: China