New drug combo aims to tame deadly fat levels in the blood
NCT ID NCT07308392
First seen Jun 24, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This Phase 2 trial tests two experimental injections, HRS-7249 and SHR-1918, in 108 adults with severely high triglycerides who are at high risk of acute pancreatitis. The study aims to see if these drugs can safely lower fat levels in the blood and reduce the chance of a pancreatitis attack. Participants are randomly assigned to receive either the drugs or a placebo, and researchers will track changes in triglyceride levels and pancreatitis events over nearly a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-7249 and SHR-1918 injections
- What this could lead to
- If successful, this could provide a new treatment option to lower dangerously high triglycerides and reduce the risk of acute pancreatitis.
- What could go wrong
- This is an early Phase 2 trial with only 108 participants, so results may not confirm effectiveness or safety. The drugs are experimental and may cause side effects or fail to outperform placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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119 people
The number who actually took part.
- Started
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Feb 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing; 2. Male or female aged ≥18 years and \<80 years on the day of signing the informed consent form. Exclusion Criteria: 1. History of gallstones at the time of screening or previously (except for patients who had their gallbladder removed more than 3 months ago); 2. Acute pancreatitis that has clinically recovered ≤4 weeks before screening or randomization; 3. 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); 4. Grade 3/4 heart failure at the time of screening or before randomization; 5. 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; 6. 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; 7. Severe infection within 3 months before screening; 8. History or presence of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases significantly affecting lipid levels at screening; 9. History or presence of hyperthyroidism or hypothyroidism at screening; 10. Poorly controlled hypertension at screening or before randomization (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); 11. 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; 12. 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; 13. Serious trauma or major surgery within 6 months before screening, or planning major surgery during the trial; 14. Plasma exchange therapy within 4 weeks before screening or randomization, or planned during the trial; 15. 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; 16. Use of weight-loss drugs or undergoing weight-altering surgery within 2 months before screening or randomization, or planned during the study; 17. 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 disorder, or alcohol-induced psychiatric or behavioral disorder); 18. 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; 19. eGFR calculated by the Modification of Diet in Renal Disease (MDRD) formula \<60 mL/min/1.73 m²; 20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN); 21. Total bilirubin or direct bilirubin ≥2 times ULN; 22. Creatine kinase (CK) \>1.5 times ULN; 23. Platelet count \<100 x 10⁹/L (or history of thrombocytopenia); 24. Hemoglobin \<60 g/L; 25. 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 ≥200 IU/ml, or if the detection lower limit is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ detection lower limit); 26. Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above 1.5 times ULN; 27. Participation in any interventional 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 investigational product before screening, whichever is longer; previous participation in non-interventional clinical trials or device-related clinical trials may be judged by the investigator for inclusion; 28. Pregnant or breastfeeding women; 29. Women of childbearing potential who have not used contraception within 30 days prior to screening; women of childbearing potential and male subjects with partners of childbearing age who refuse to avoid donating sperm/eggs from the time of signing the informed consent until the end of the follow-up period, or refuse to comply with relevant contraceptive requirements; 30. Other conditions deemed by the investigator to make the subject unsuitable for participation in the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210029, China