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Tests treatment safety and results for Severe Hypertriglyceridemia With a High Risk of Acute...
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
ClinicalTrials.gov ID: NCT07308392
What this study is testing
What is HRS-7249 injection set?
HRS-7249 injection set is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for severe hypertriglyceridemia with a high risk of acute pancreatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
- Male or female aged ≥18 years and \<80 years on the day of signing the informed consent form.
You likely can't join if
- 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...
- Grade 3/4 heart failure at the time of screening or before randomization;
- Acute coronary syndrome (such as myocardial infarction, unstable angina), history of coronary artery bypass grafting, percutaneous coronary...
- Severe arrhythmias within 3 months before screening or randomization, such as recurrent symptomatic frequent ventricular premature beats, ventricular...
See the full eligibility criteria
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
- Male or female aged ≥18 years and \<80 years on the day of signing the informed consent form.
- 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 (such as myocardial infarction, unstable angina), history of coronary artery bypass grafting, percutaneous coronary intervention, peripheral artery revascularization, cerebrovascular diseases...
- Severe arrhythmias within 3 months before screening or randomization, such as recurrent symptomatic frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation with rapid ventricular rate;
- 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 with any of the following: a. Newly diagnosed within 12 weeks before screening or randomization; b. HbA1c ≥8.0% at screening; c. Type 1 diabetes;
- Unstable or severe liver, kidney, cardiovascular, psychiatric, neurological, endocrine, hematologic, or other diseases at screening or before randomization, where the investigator determines participation poses an...
- Serious trauma or major surgery within 6 months before screening, or planning major surgery during the trial;
- Plasma exchange therapy within 4 weeks before screening or randomization, or planned during the trial;
- Use of other drugs significantly affecting lipid levels within 4 weeks before screening or randomization, or planned during the trial, such as traditional Chinese medicine containing statins (e.g., Zhibituo, Zhibitai)...
- Use of weight-loss drugs or undergoing weight-altering surgery within 2 months before screening or randomization, or planned during the study;
- History of drug abuse or alcohol abuse (including heavy drinking [average ethanol intake \>80 g/day], previously diagnosed alcohol harmful use, alcohol dependence, alcohol poisoning, alcohol withdrawal, alcohol-related...
- Significant lifestyle changes within 4 weeks before screening or randomization, or refusal to follow lifestyle guidance or limit alcohol intake to \<30 g/day during the study;
- eGFR calculated by the Modification of Diet in Renal Disease (MDRD) formula \<60 mL/min/1.73 m²;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN);
- Total bilirubin or direct bilirubin ≥2 times ULN;
- Creatine kinase (CK) \>1.5 times ULN;
- Platelet count \<100 x 10⁹/L (or history of thrombocytopenia);
- Hemoglobin \<60 g/L;
- Confirmed active syphilis, positive test result for human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab), positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies/ml (or...
- Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above 1.5 times ULN;
- Participation in any treatment drug clinical trial within 3 months prior to screening (participation is defined as administration of the investigational product to the subject), or still within 5 half-lives of the...
- Pregnant or breastfeeding women;
- Women of childbearing potential who have not used contraception within 30 days prior to screening; women of childbearing potential and male people with partners of childbearing age who refuse to avoid donating...
- Other conditions deemed by the investigator to make the subject unsuitable for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.