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NCT Number: NCT04709536

A Study of IBI306 in Participants With Hypercholesterolemia

This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, China

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 ≤ 75 years of age
  • Diagnosis of hypercholesterolemia
  • LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
  • Very high or high cardiovascular risk
  • TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

  • Uncontrolled hypertension
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Severe renal dysfunction
  • Known sensitivity to any of the products to be administered during dosing

Treatment and study plan

IBI306

Drug

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Placebo

Drug

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Primary outcomes

  1. 1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12

    Time frame: Baseline to week12

Secondary outcomes

  1. The percent of subjects with LDL-C reduction no less than 50% from baseline

    Time frame: Baseline to week24

  2. The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)

    Time frame: Baseline to week24

  3. The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline

    Time frame: Baseline to week24

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Oct 31, 2024

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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