A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors

Recruiting Phase 2 Phase 3 Interventional Study
Hypercholesterolemia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd · Industry
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About This Trial

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent. 2. TG ≤ 5.6 mmol/L. 3. LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD ri…
Contacts

Miaomiao Shi

+86-0518-82342973

miaomiao.shi@hengrui.com

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