A Study of IBI306 in Participants With Hypercholesterolemia

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: IBI306; Drug: Placebo

• Registration Number: NCT04709536
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-02-09
• Primary Completion: 2021-11-09
• Study Completion: 2022-01-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI306	IBI306	IBI306 administered subcutaneously (SC)
Placebo	Placebo	administered subcutaneously (SC)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China