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A Study of IBI306 in Participants With Hypercholesterolemia

NCT04709536 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-10-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

IBI306

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2021-11-09
Completion
2022-01-28

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709536 on ClinicalTrials.gov