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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Biological: AK102; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330009
      • The Third Hospital of Nanchang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered placebo by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
Experimental: AK102 regimen 1	Biological: AK102; Administered AK102 by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 non HDL-C 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

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: AK102-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No