RecruitingPhase 2

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

China108 participantsStarted 2026-02-25

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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Inclusion 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.

Exclusion criteria

✕. 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 (such as stroke, transient ischemic attack), heart failure hospitalization, etc., within 3 months before screening or randomization;
✕. 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;

What they're measuring

Percentage change in mean TG from baseline at weeks 44 and 48 of treatment

Timeframe: at 44＆48 weeks after the start of administration

Proportion of subjects experiencing AP during the double-blind treatment period

Timeframe: within 48 weeks after the start of administration

Trial details

NCT IDNCT07308392

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Chuo Tong

+0518-82342973 chuo.tong.ct1@hengrui.com

View on ClinicalTrials.gov More Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis trials