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

NCT07308392 | Recruiting Phase 2

• 1 other identifier: HRS-7249-202
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis

Outcome Measures

Primary Outcomes (2)

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

  at 44＆48 weeks after the start of administration

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

  within 48 weeks after the start of administration

Secondary Outcomes (2)

• During the double-blind treatment period, the time and severity of the first occurrence of AP

  within 48 weeks after the start of administration

• During the double-blind treatment period, the proportion of subjects who developed HTG-AP, the time to first occurrence of HTG-AP, and its severity

  within 48 weeks after the start of administration

Study Arms (4)

HRS-7249 injection

EXPERIMENTAL

Drug: HRS-7249 injection set

HRS-7249 injection placebo

PLACEBO COMPARATOR

Drug: HRS-7249 injection placebo set

SHR-1918 injection

EXPERIMENTAL

Drug: SHR-1918 injection set

SHR-1918 injection placebo

PLACEBO COMPARATOR

Drug: SHR-1918 injection placebo set

Interventions

HRS-7249 injection set DRUG

HRS-7249 injection set

HRS-7249 injection

SHR-1918 injection set DRUG

SHR-1918 injection set

SHR-1918 injection

HRS-7249 injection placebo set DRUG

HRS-7249 injection placebo set

HRS-7249 injection placebo

SHR-1918 injection placebo set DRUG

SHR-1918 injection placebo set

SHR-1918 injection placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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;
• 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 unacceptable risk to the subject;
• 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), other lipid-lowering drugs and supplements (e.g., probucol, bile acid sequestrants, niacin, over-the-counter drugs, red yeast rice), GLP-1 agonists, other incretin analogues;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Chuo Tong

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-11

Locations

CN (1)