Skip to main content
OpenTrials
Completed

NCT Number: NCT04031742

A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

About this study

This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females ≥ 18 to ≤ 80 years of age
  • Diagnosis of homozygous familial hypercholesterolemia
  • LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
  • Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
  • Bodyweight of ≥ 40 kg at screening

Exclusion criteria

  • History of liver transplant
  • Uncontrolled hypertension
  • Moderate to severe renal dysfunction
  • Active liver disease or hepatic dysfunction
  • Known sensitivity to any of the products to be administered during dosing

Treatment and study plan

IBI306

Biological

Administered by subcutaneous injection

Primary outcomes

  1. Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).

    Time frame: Baseline and Week 12

  2. Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline and Week 12

Other outcomes

  1. Number of investigational product-related adverse events.

    Time frame: Baseline and Week 12

  2. Number of ADA and Nab.

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2019
Registry last updated
Aug 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.