Actively Recruiting
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-03-03
108
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II clinical trial evaluating the efficacy and safety of HRS-7249 and SHR-1918 in patients with severe hypertriglyceridemia at high risk of acute pancreatitis
CONDITIONS
Official Title
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing
- Male or female aged 518 years and <80 years on the day of signing the informed consent form
You will not qualify if you...
- History of gallstones at the time of screening or previously (except for patients who had their gallbladder removed more than 3 months ago)
- Acute pancreatitis that has clinically recovered 4 weeks before screening or randomization
- Malignant tumor within 5 years before screening or randomization (except for non-melanoma skin cancer or cervical carcinoma in situ that has been radically treated)
- Grade 3/4 heart failure at the time of screening or before randomization
- Acute coronary syndrome, history of coronary artery bypass grafting, percutaneous coronary intervention, peripheral artery revascularization, cerebrovascular diseases, heart failure hospitalization within 3 months before screening or randomization
- Severe arrhythmias within 3 months before screening or randomization
- Severe infection within 3 months before screening
- History or presence of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases significantly affecting lipid levels at screening
- History or presence of hyperthyroidism or hypothyroidism at screening
- Poorly controlled hypertension at screening or before randomization (systolic blood pressure 180 mmHg and/or diastolic blood pressure 110 mmHg)
- Diabetes newly diagnosed within 12 weeks before screening or randomization, HbA1c 8.0% at screening, or type 1 diabetes
- Unstable or severe liver, kidney, cardiovascular, psychiatric, neurological, endocrine, hematologic, or other diseases at screening or before randomization that pose unacceptable risk
- Serious trauma or major surgery within 6 months before screening or planned during the trial
- Plasma exchange therapy within 4 weeks before screening or planned during the trial
- Use of other drugs significantly affecting lipid levels within 4 weeks before screening or planned during the trial
- Use of weight-loss drugs or weight-altering surgery within 2 months before screening or planned during the study
- History of drug or alcohol abuse, including heavy drinking
- Significant lifestyle changes within 4 weeks before screening or refusal to follow lifestyle guidance or limit alcohol intake to <30 g/day during the study
- eGFR <60 mL/min/1.73 m�b2
- ALT or AST 3 times the upper limit of normal
- Total bilirubin or direct bilirubin 2 times upper limit of normal
- Creatine kinase >1.5 times upper limit of normal
- Platelet count <100 x 10�b9/L or history of thrombocytopenia
- Hemoglobin <60 g/L
- Confirmed active syphilis, positive HIV antibody, positive HCV antibody, or positive hepatitis B surface antigen with high HBV-DNA
- Thyroid-stimulating hormone below normal or above 1.5 times upper limit of normal
- Participation in any interventional drug clinical trial within 3 months prior to screening or still within 5 half-lives of the investigational product
- Pregnant or breastfeeding women
- Women of childbearing potential who have not used contraception within 30 days prior to screening or refuse contraception during the study
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
C
Chuo Tong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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