A Study of IBI306 in Participants With Hypercholesterolemia

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04709536
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Feb 9, 2021
Status verified
Oct 2024
Primary completion
Nov 9, 2021
Completion
Jan 28, 2022

Study Design

Enrollment
306 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI306
    IBI306 administered subcutaneously (SC)
  • Placebo Comparator: Placebo
    administered subcutaneously (SC)

Primary Outcome Measure

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

Related Studies