Status:
UNKNOWN
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Conditions:
Hyperlipidemic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with...
Eligibility Criteria
Inclusion
- Regularly taking any moderate-intensity or higher dose\* of statin stabilization therapy for ≥4 weeks at screening:
- ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
- ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
- ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
- Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose\* statin stabilization therapy for ≥4 weeks;
- a) Fasting LDL-C ≥ 2.6 mmol/L.
- Fasting triglycerides ≤ 5.6 mmol/L.
Exclusion
- Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%).
- eGFR \<30ml/min/1.73m2 at the screening visit.
- CK \>5times ULN at the screening visit.
Key Trial Info
Start Date :
November 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2025
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT06109831
Start Date
November 24 2023
End Date
September 27 2025
Last Update
May 16 2024
Active Locations (1)
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1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009