Hyperlipidemia
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. the age must be at least 18 years old, and both men and women are eligible; 2. the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L; 3. Fasting TG≥ 1.7 mmol/L; 4. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.
Exclusion criteria
1. poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization; 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) \> 3× upper limit of normal (ULN), or total bilirubin \> 2×ULN; 3. Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN； 4. The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m\^2; 5. Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change of serum LDL-C from baseline | Baseline and Week 24 |
| The percentage change in serum TG from baseline | Baseline and Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline | Baseline and Week 24 |
| The percentage change in serum total cholesterol (TC) from baseline | Baseline and Week 24 |
| The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24 | Baseline and Week 24 |
| The percentage change of serum apolipoprotein A1 (ApoA1) from baseline | Baseline and Week 24 |
| The change from baseline in serum LDL-C | Baseline and Week 24 |
| The change from baseline in serum TG | Baseline and Week 24 |
| The change from baseline in serum non-HDL-C | Baseline and Week 24 |
| The change from baseline in serum TC | Baseline and Week 24 |
| The change from baseline in serum ApoB | Baseline and Week 24 |
| The change from baseline in serum ApoA1 | Baseline and Week 24 |
| Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a)) | Baseline and Week 24 |
| Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C) | Baseline and Week 24 |
| LDL-C goal attainment rates at Week 24, overall and by risk subgroup | Baseline and Week 24 |
| Absolute and percentage change from baseline in serum non-HDL-C at Week 48 | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum ApoB at Week 48 | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum Lp(a) at Week 48 | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum TC at Week 48 | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum TG at Week 48 | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum HDL-C at Week 48 | Baseline and Week 48 |
| Absolute and percentage change from baseline in serum ApoA1 at Week 48 | Baseline and Week 48 |
| LDL-C goal attainment rates at Week 48, overall and by risk subgroup | Baseline and Week 48 |
| The incidence and severity of adverse events (AEs) throughout the study | up to week 52 |
| Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study | up to week 52 |
| Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study | up to week 52 |
Countries
China
Contacts
CONTACTSheng Qi
Outcome results
None listed