CompletedPhase 3

Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

China804 participantsStarted 2020-04-29

Plain-language summary

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Diagnosis of HoFH or HeFH
✕. Uncontrolled hypertension
✕. Uncontrolled hyperthyroidism or hypothyroidism
✕. Severe renal dysfunction
✕. Known sensitivity to any of the products to be administered during dosing

What they're measuring

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48

Timeframe: Week 48

Trial details

NCT IDNCT04289285

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-09

View on ClinicalTrials.gov More Hypercholesterolemia trials