Hyperlipidemic
Conditions
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 Hyperlipidemic.
Interventions
DRUGSHR-1918
SHR-1918
DRUGSHR-1918 placebo
SHR-1918 placebo
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Regularly taking any moderate-intensity or higher dose\* of statin stabilization therapy for ≥4 weeks at screening: 1. ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L; 2. ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L; 3. ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L. 2. 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. 3. Fasting triglycerides ≤ 5.6 mmol/L.
Exclusion criteria
1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%). 2. eGFR \<30ml/min/1.73m2 at the screening visit. 3. CK \>5times ULN at the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in calculated LDL-C from baseline to week 16 | from baseline to week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Change in calculated LDL-C from baseline to week 16 | from baseline to week 16 |
Countries
China
Outcome results
None listed