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Active, Not Recruiting

NCT Number: NCT06275724

Specified Drug-use Survey of Leqvio for s.c. Injection.

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Familial Hypercholesterolaemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Homozygous Familial Hypercholesterolemia Hypercholesterolaemia Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

15 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Handa, Aichi-ken, Japan

Loading trial locations.

About this study

Uncontrolled, central registration system, multicenter, special drug use-results surveillance.

This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan.

The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio.
  • Patients who received treatment with Leqvio as per the package insert.

Exclusion criteria

  • Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past.
  • Patients participating in other interventional studies at the time of informed consent.
  • Patients planning to participate in other interventional studies during this survey.

Treatment and study plan

Inclisiran

Other

Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study.

Primary outcomes

  1. Number of patients with adverse events

    Time frame: Up to 24 months

    To evaluate the long-term safety profile of Leqvio

  2. Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions

    Time frame: Up to 24 months

    To evaluate the long-term safety profile of Leqvio

Secondary outcomes

  1. Number of patients with adverse events leading to discontinuation of treatment with the product

    Time frame: Up to 24 months

    To evaluate the tolerability of Leqvio

  2. Percent change from baseline in LDL-C levels

    Time frame: Month 24

    To evaluate the efficacy of Leqvio based on LDL-C levels

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Jul 8, 2026

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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