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NCT Number: NCT05255094

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

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, China

About this study

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject understand and voluntarily sign the written Inform Consent Form (ICF).
  • Male or female ≥ 18 to ≤ 80 years of age.
  • 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.
  • TG ≤ 4.5 mmol/L (400 mg/dl).

Exclusion criteria

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

Treatment and study plan

AK102

Biological

Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Placebo

Drug

Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Primary outcomes

  1. Percentage change from baseline of serum LDL-C level

    Time frame: At week 12

    Percentage change from baseline of serum LDL-C level

Secondary outcomes

  1. Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels

    Time frame: Week 0-12

    Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-

  2. The incidence and severity of adverse events (AE)

    Time frame: Week 0-12

    The incidence and severity of adverse events (AE)

  3. To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

    Time frame: Week 0-12

    To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

  4. Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

    Time frame: Week 0-12

    Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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