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Clinical Trials in China / NCT07388420
Recruiting Not applicable

Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis

NCT07388420 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Shenyang Military Region
Phase
Not applicable
Started
2026-01-02
Last updated
2026-09-25

Condition(s) studied

Hypertriglyceridemia Induced Acute Pancreatitis

Investigational drug(s) / intervention(s)

Evolocumab 140 MG/ML [Repatha] →Conventional lipid-lowering therapy →

Evolocumab 140 MG/ML [Repatha]: The clinicians strictly follow the treatment strategy for HTG-AP as stipulated in the 2021 "Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis" to provide conventional lipid-lowering treatment for the patients, including dietary adjustments, fibrates, low-molecular-weight heparin, and insulin, etc. On the basis of conventional lipid-lowering treatment, 140mg of evolocumab is added by slow subcutaneous injection every two weeks, and the patients' responses are observed during this period.

Conventional lipid-lowering therapy: This group only receives conventional lipid-lowering treatment without adding evolocumab.

Study summary

The severity of hypertriglyceridemia induced acute pancreatitis (HTG-AP) is closely related to the serum triglyceride (TG) levels. The higher the TG levels, the greater the risk of developing severe acute pancreatitis (SAP). Previous expert consensus has pointed out that the key to treating HTG-AP is to rapidly lower serum TG levels to below 5.65 mmol/L. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which is often used to treat familial hypercholesterolemia, mixed dyslipidemia and atherosclerotic cardiovascular disease. At the same time, evolocumab also has the effect of reducing TG and may provide a feasible option for the management of HTG-AP. However, its efficacy and safety in reducing TG in patients with HTG-AP remain controversial. This study is a multicenter randomized controlled trial to evaluate the efficacy and safety of adding evolocumab to conventional lipid-lowering therapy in patients with HTG-AP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 within one week before enrollment * Patients who have used evolocumab within one month before enrollment * 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

Primary outcome measure(s)

  • The TG levels on the 3rd and 7th days after treatment — 3 days and 7days
  • The rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L on the 3rd and 7th days after treatment — 3 days and 7 days

Trial sites (1)

FacilityCityRegionStatus
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) Shenyang Liaoning Recruiting

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Other trials for the same condition

GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07388420 on ClinicalTrials.gov ↗ ← All trials in China