NCT04173793

A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of AK102 in Patients With Heterozygous Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.

Conditions

• Heterozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	AK102	Administered by subcutaneous injection
DRUG	Placebo	Administered by subcutaneous injection
DRUG	Statins and/or Ezetimibe	Lipid-lowering therapies

Timeline

• Start date: 2019-11-18
• Primary completion: 2022-09-26
• Completion: 2022-09-26
• First posted: 2019-11-22
• Last updated: 2023-03-02

Locations

2 sites across 1 country: China