Primary hypercholesterolemia and mixed dyslipidemia with statin intolerance or inadequate response
Conditions
Interventions
Experimental Group A:Inusimab Injection 150 mg, subcutaneous injection, once every 2 weeks, for 12 consecutive weeks of treatment
Experimental Group B:Combination therapy: Inusimab Injection 150 mg subcutaneously once every two weeks for 12 consecutive weeks, on a background of atorvastatin.
Sponsors
Xianning Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-75 years old, both sexes; 2. Patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) or mixed dyslipidemia who meet the diagnostic criteria of "Chinese Guidelines for the Management of blood lipids (2023)"; 3, baseline LDL-C>=3.4mmol/L (or >=1.8mmol/L in patients with atherosclerotic cardiovascular disease (ASCVD)) (baseline lipid test was valid for the 14-day screening period); 4. Diagnostic criteria for statin intolerance: at least one of the following must be met: Muscle-related intolerance: Intolerable muscle symptoms (e.g., myalgia, fatigue, cramps) with or without elevated creatine kinase (CK) during the use of any statin (at any dose), which resolved or resolved after discontinuation, and intolerance to at least two statins (one of which was the lowest starting dose), or intolerance to one statin but intolerance to any other. (2) Liver function related intolerance: ALT and/or AST increased more than 3 times the upper limit of normal value (>3×ULN) during the use of any statin, and liver function returned to normal or returned to <=1.5×ULN after drug withdrawal. (3) Other intolerance: patients were unable to tolerate other adverse reactions of statins (such as gastrointestinal reactions, allergic reactions, etc.), and were not suitable to continue using statins according to the investigator's judgment. 5. The patient was diagnosed as "poor statin response" after receiving moderate or higher doses of statin therapy (atorvastatin 20mg,qd maximum dose not exceeding 80mg,qd or rosuvastatin 5-20mg,qd) for two weeks, but still did not reach the target value of LDL-C. 6. Have the ability of independent behavior, can cooperate to complete the study visit, drug administration and related examinations; 7. Agree to participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (Any of the following conditions will result in exclusion from enrollment) 1. Patients with a history of allergy to Inusimab Injection or Atorvastatin Calcium Tablets, or those who have experienced severe adverse reactions following previous use of PCSK9 inhibitors or statins. 2. Patients with cerebral hemorrhage within the past 3 months, or those with New York Heart Association (NYHA) cardiac function classification Class ?–?. 3. Participants who have enrolled in other clinical trials of lipid-lowering drugs within the past 3 months, or those who have used special lipid-regulating agents such as other PCSK9 inhibitors, lomitapide or mipomersen within 4 weeks prior to enrollment. 4. Pregnant or lactating women, as well as males and females of childbearing potential without effective contraceptive measures. 5. Patients with active liver diseases (viral hepatitis, liver cirrhosis, autoimmune hepatitis, etc.), active connective tissue diseases, or malignant tumors. 6. Subjects with severe underlying diseases of metabolism, immunity, hematology, cardiovascular system, nervous system or respiratory system, or those deemed by the investigator to be likely to interfere with study participation or outcome assessment. 7. Subjects with a history of psychiatric disorders, drug abuse or alcohol dependence, or those considered unsuitable for participation by the investigator. 8. Any other conditions judged by the investigator that may interfere with study participation or evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline at Week 12 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage changes and absolute changes from baseline in total cholesterol (TC), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and lipoprotein(a) [Lp(a)] at Week 12 of treatment.;LDL-C attainment rate at Week 12 of treatment: LDL-C < 1.8 mmol/L in patients with ASCVD, LDL-C < 2.6 mmol/L in non-ASCVD patients, accompanied by a reduction of =50% from baseline; normalization rate of lipid indicators (judged in accordance with the Chinese Guidelines for Lipid Management (2023)).;Subject medication compliance; | — |
Countries
China
Contacts
Public ContactLi Bin
Xianning Central Hospital
Outcome results
None listed