Adding evolocumab to usual lipid-lowering care for acute pancreatitis caused by very high triglycerides
Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis: A Pilot Randomised Controlled Trial
This study will try adding evolocumab to standard lipid-lowering care for adults hospitalized with hypertriglyceridemia-induced acute pancreatitis to see if it lowers triglycerides faster and reaches target levels within a week.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Drugs / interventions | evolocumab |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07388420 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial will enroll 40 patients with hypertriglyceridemia-induced acute pancreatitis and randomly assign them 1:1 to conventional lipid-lowering therapy with or without added evolocumab. The primary endpoints are serum triglyceride levels at days 3 and 7 and the proportions of patients reaching triglyceride thresholds of <5.65 mmol/L and <1.7 mmol/L at those time points. Secondary endpoints include other lipid measures (TC, HDL, LDL, lipoprotein(a)) at days 3 and 7, incidence of recurrent or severe acute pancreatitis and other complications, length of hospital stay, and total hospitalization costs. Treatment is provided in the inpatient setting at participating hospital site(s).
Who should consider this trial
Good fit: Adults aged 18–75 with hypertriglyceridemia-induced acute pancreatitis and mixed hyperlipidemia who can give informed consent and have not recently received lipid-lowering drugs or blood purification are ideal candidates.
Not a fit: Patients who recently received lipid-lowering therapy or blood purification, those who used evolocumab within one month, pregnant or breastfeeding individuals, people with serious life-limiting comorbidities, or those with multiple drug/food allergies may not receive benefit or be eligible.
Why it matters
Potential benefit: If successful, adding evolocumab could produce faster triglyceride reduction, which may lower the risk of severe pancreatitis and shorten hospital stays.
How similar studies have performed: PCSK9 inhibitors such as evolocumab are well established for lowering LDL and can modestly reduce triglycerides, but randomized evidence specifically testing their use in hypertriglyceridemia-induced acute pancreatitis is limited, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18\~75 years * Patients with HTG-AP * Mixed hyperlipidemia * Sign the informed consent form Exclusion Criteria: * Patients who have received lipid-lowering drugs or blood purification treatment * Patients who have used evolocumab within one month before admission * Patients who are accompanied by diseases that can seriously affect the survival * Patients who have participated in the clinical research of other drugs within one month * Patients who are pregnant or breastfeeding * Patients with allergic asthma, allergic urticaria, eczema, and those who have a clear history of multiple drug and food allergies * Other circumstances that researchers consider not suitable for participation in this study
Where this trial is running
Shenyang, Liaoning
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xingshun Qi
- Email: xingshunqi@126.com
- Phone: 18909881019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.