Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840, China
Location status: Recruiting
Recruiting
NCT Number: NCT07388420
Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis
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.
Recruiting
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Request InfoKey information
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Overall, 40 patients with HTG-AP will be included. These patients will be randomly assigned in a 1:1 ratio to the conventional lipid-lowering therapy group and the conventional lipid-lowering therapy + evolocumab group. The primary endpoints are the TG levels at days 3 and 7 after treatment, and the rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L at the same time points. Secondary endpoints include blood levels of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and lipoprotein(a) at days 3 and 7; the incidence of recurrent acute pancreatitis (RAP), SAP, and other complications; as well as the length of hospital stay and total hospitalization costs.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Evolocumab 140 MG/ML [Repatha]
DrugThe 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.
Other names: Dietary adjustments, Fibrates, Low-molecular-weight heparin, Insulin
Conventional lipid-lowering therapy
DrugThis group only receives conventional lipid-lowering treatment without adding evolocumab.
Other names: Dietary adjustments, Fibrates, Low-molecular-weight heparin, Insulin
Primary outcomes
-
The TG levels on the 3rd and 7th days after treatment
Time frame: 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
Time frame: 3 days and 7 days
Secondary outcomes
-
The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment
Time frame: 3 days and 7days
-
The incidence of RAP, SAP, and other complications
Time frame: 6 months
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
General Hospital of Shenyang Military Region
Other
Registry information
Official study title
Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis: A Pilot Randomised Controlled Trial
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 5, 2026
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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