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

January 30, 2026 updated by: Xingshun Qi, General Hospital of Shenyang Military Region

Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis: A Pilot Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • Recruiting
        • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional lipid-lowering therapy + Evolocumab group
Drug: 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.
Other Names:
  • Insulin
  • Low-molecular-weight heparin
  • Dietary adjustments
  • Fibrates
Active Comparator: Conventional lipid-lowering therapy group
Drug: Conventional lipid-lowering therapy
This group only receives conventional lipid-lowering treatment without adding evolocumab.
Other Names:
  • Insulin
  • Low-molecular-weight heparin
  • Dietary adjustments
  • Fibrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The TG levels on the 3rd and 7th days after treatment
Time Frame: 3 days and 7days
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
3 days and 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment
Time Frame: 3 days and 7days
3 days and 7days
The incidence of RAP, SAP, and other complications
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHNKKY-HTGAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertriglyceridemia Induced Acute Pancreatitis

Clinical Trials on Evolocumab 140 MG/ML [Repatha]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe