Hyperlipidemia
Conditions
Brief summary
Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials
Interventions
DRUGSHR-1918; SHR-1918 Placebo
SHR-1918/SHR-1918 Placebo,two administration
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible; 2. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions; 3. TG≤5.6mmol/L.
Exclusion criteria
1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN; 2. Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value); 3. Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN); 4. Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN); 5. Glomerular filtration rate (eGFR)\<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in calculated LDL-C from baseline to week 24 | from baseline to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in calculated TG from baseline to week 24 | from baseline to week 24 |
Countries
China
Outcome results
None listed