A Study of IBI306 in Participants With Hypercholesterolemia

October 29, 2024 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Males and females ≥ 18 to ≤ 75 years of age
  2. Diagnosis of hypercholesterolemia
  3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
  4. Very high or high cardiovascular risk
  5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

  1. Uncontrolled hypertension
  2. Uncontrolled hyperthyroidism or hypothyroidism
  3. Severe renal dysfunction
  4. Known sensitivity to any of the products to be administered during dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI306
IBI306 administered subcutaneously (SC)
Drug: IBI306
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
Placebo Comparator: Placebo
administered subcutaneously (SC)
Drug: Placebo
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
Time Frame: Baseline to week12
Baseline to week12

Secondary Outcome Measures

Outcome Measure
Time Frame
The percent of subjects with LDL-C reduction no less than 50% from baseline
Time Frame: Baseline to week24
Baseline to week24
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Time Frame: Baseline to week24
Baseline to week24
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Time Frame: Baseline to week24
Baseline to week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Actual)

November 9, 2021

Study Completion (Actual)

January 28, 2022

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI306B201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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