Hypertriglyceridemia
Conditions
Interventions
Test Group 4:Subcutaneous injection of CREPT-618 2.5mg/kg
Test Group 3:Subcutaneous injection of CREPT-618 2.0mg/kg
Test Group 2:Subcutaneous injection of CREPT-618 1.5mg/kg
Test Group 1:Subcutaneous injection of CREPT-618 0.8mg/kg
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years, any gender. 2. Clinical evidence of fasting triglycerides (TG) >=2.3 mmol/L and =2.3 mmol/L and <=5.7 mmol/L at both screening and enrollment. Participants may have undergone dietary control and received monotherapy lipid-lowering treatment before screening but with unsatisfactory results. 3. Body Mass Index (BMI): 22–35 kg/m² (inclusive). 4. Diabetic patients receiving GLP-1 and/or GIP receptor agonist treatment must agree to discontinue these medications at least until the end of the study (from 7 days before the first dose to the end of the study) and use other medications to maintain good blood glucose control. 5. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Screening test results were judged by the investigator to be clinically significant and met the following criteria: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) >2.0×ULN; Estimated glomerular filtration rate (eGFR) =150mmHg or diastolic blood pressure =95mmHg), including no use or stable doses of antihypertensive medications. 5.The ECG was abnormal and clinically significant as judged by the investigator, or QTcF>450ms in men or >470ms in women. 6.Patients who were positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), human immunodeficiency virus (HIV) antibody or serum treponema pallidum specific antibody (TP-Ab) at screening; Or use of anti-HCV drugs within 6 months before screening. 7.A history of pancreatitis. 8.Use of additional medications/therapies for weight loss within 1 month before screening and planned for the duration of the study. 9.Participants had Participated in other clinical trials and received the corresponding study drug within 3 months before screening. 10.Participants who had strenuous exercise or had significant changes in exercise or dietary habits during the study. 11.History of fainting due to acupuncture or blood transfusion, or inability to tolerate venipuncture. 12.Within the previous 3 months, had a history of blood donation, or had a total blood loss of more than 300ml due to other reasons (excluding menstrual blood loss for women). 13.Within the previous 6 months, had an acute coronary syndrome or cerebrovascular event; or within the previous 3 months, underwent major surgery, peripheral vascular reconstruction, or elective percutaneous coronary intervention; or planned to undergo major surgery during the study period. 14.Female participants who are in lactation period, pregnancy period, planning pregnancy, have reproductive capacity but do not wish to take effective contraceptive measures from the start of signing the informed consent until 3 months after the last use of the drug (using at least 1 effective contraceptive method). 15.Male participants who do not wish to take effective contraceptive measures from the start of signing the informed consent until 3 months after the last use of the drug (using at least 1 effective contraceptive method). 16.Those who cannot accept a uniform diet or have special dietary requirements. 17.The researcher determines that other reasons make them unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events after 14 days of treatment (D14);Change and percentage change in triglycerides from baseline after 14 days of treatment (D14); | — |
Secondary
| Measure | Time frame |
|---|---|
| The level of CREPT;Blood drug concentration; | — |
Countries
China
Contacts
Public ContactZeng Yangbin
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed