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

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Biological: AK102; Drug: Placebo

• Registration Number: NCT05260411
• Lead Sponsor: Akeso

Brief 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.

Study Timeline

• Study Start: 2022-01-26
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

1. Subject understand and voluntarily sign the written Inform Consent Form (ICF).
2. Male or female ≥ 18 to ≤ 80 years of age.
3. The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
4. TG ≤ 4.5 mmol/L (400 mg/dl)

Exclusion Criteria

1. Known homozygous familial hypercholesterolemia.
2. Received PCSK9 inhibitors within 6 months before randomization.
3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
4. Severe renal dysfunction.
5. Previously received organ transplantation.
6. Uncontrolled hypothyroidism or hyperthyroidism.
7. Uncontrolled hypertension.
8. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
9. History of malignancy of any organ system within the past 5 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK102 regimen 2	AK102	-
Placebo	Placebo	-
AK102 regimen 1	AK102	-

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline of serum LDL-C level	At week 12

Secondary Outcome Measures

Name	Time	Method
Evaluate the changes of AK102 PK parameters(Tmax)	Week 0-24
Evaluate the changes of AK102 PK parameters(Vd)	Week 0-24
Evaluate the changes of AK102 PK parameters(t1/2)	Week 0-24
The number and percentage of anti AK102 antibody (ADA)positive subjects	Week 0-24
the time of nab positive	Week 0-24
Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels	Week 0-24
The incidence and severity of adverse events (AE)	Week 0-24
Evaluate the changes of AK102 PK parameters(AUC）	Week 0-24
Evaluate the changes of free PCSK9 concentration	Week 0-24
Evaluate the changes of AK102 PK parameters(Cmax)	Week 0-24
Evaluate the changes of AK102 PK parameters(CL)	Week 0-24
Evaluate the changes of AK102 PK parameters(MRT)	Week 0-24
The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects	Week 0-24
the time of ADA positive	Week 0-24

Trial Locations

Locations (2)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Zhongshan Hospital, Fudan Hospital; 🇨🇳 Shanghai, China