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

Phase 3

Completed

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

• Registration Number: NCT05255458
• Lead Sponsor: Akeso

Brief 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.

Study Timeline

• Study Start: 2021-11-04
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Subject understand and voluntarily sign the written Inform Consent Form (ICF), which must be signed before performing the study procedures.
2. Male or female patients aged between 18 and 80 years (including upper and lower limits).
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. Triglyceride ≤ 4.5 mmol/L (400 mg/dl).

Exclusion Criteria

1. Homozygous Familial Hypercholesterolemia (HoFH).
2. Received PCSK9 inhibitors within 6 months before randomization.
3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
4. Severe liver and 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.
10. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AK102 regimen 1	AK102	-

Primary Outcome Measures

Name	Time	Method
Precentage change from baseline of serum LDL-C level	At week 52
The incidence and severity of adverse events (AE)	Week 0-52

Secondary Outcome Measures

Name	Time	Method
Value and percentage change from baseline of serum non HDL-C levels	Week 0-52
Value and percentage change from baseline of serum TC levels	Week 0-52
Value and percentage change from baseline of serum TG levels	Week 0-52
Value and percentage change from baseline of serum ApoB levels	Week 0-52
Value and percentage change from baseline of serum HDL-C levels	Week 0-52
Value and percentage change from baseline of serum ApoA-I levels	Week 0-52
Value and percentage change from baseline of serum Lp(a) levels	Week 0-52
Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration	Week 0-52
Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity	Week 0-52

Trial Locations

Locations (1)

The Third Hospital of Nanchang; 🇨🇳 Nanchang, Jiangxi, China