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Completed

NCT Number: NCT04173403

A Long-term Study of AK102 in Patients With Hypercholesterolemia

This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent.
  • Body weight ≥ 40 kg for both men and women.
  • Participated in the AK102-202 study, and completed the AK102-202 study last visit.

Exclusion criteria

  • Poor compliance in AK102-202 study per investigator's judgement.
  • AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
  • Prior use of PCSK9 inhibitors other than AK102.

Treatment and study plan

450mg AK102

Drug

AK102 Q4W

300mg AK102

Drug

AK102 Q4W

150mg AK102

Drug

AK102 Q2W

Statins and/or Ezetimibe

Drug

Lipid-lowering therapies

Primary outcomes

  1. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52

    Time frame: Week 52

Secondary outcomes

  1. Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0

    Time frame: From baseline through 52 weeks

  2. Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol

    Time frame: From baseline through 52 weeks

  3. Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol

    Time frame: From baseline through 52 weeks

  4. Percent Change From Baseline in Serum Triglyceride (TG) cholesterol

    Time frame: From baseline through 52 weeks

  5. Percent Change From Baseline in Apolipoprotein B (Apo B)

    Time frame: From baseline through 52 weeks

  6. Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)

    Time frame: From baseline through 52 weeks

  7. Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)

    Time frame: From baseline through 52 weeks

  8. Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Time frame: From baseline through 52 weeks

  9. Concentrations of AK102 in Serum

    Time frame: From baseline through 52 weeks

  10. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    Time frame: From baseline through 52 weeks

    The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Collaborators

  • AD Pharma (Guangdong)

Registry information

Official study title

A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2019
Registry last updated
Mar 2, 2023

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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