A Study of IBI306 in Participants With Hypercholesterolemia

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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