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

NCT07388420 | Recruiting

• 1 other identifier: XHNKKY-HTGAP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertriglyceridemia Induced Acute Pancreatitis

Keywords

Hypertriglyceridemia Induced Acute Pancreatitis; Evolocumab; Conventional lipid-lowering therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment

  3 days and 7days

• The incidence of RAP, SAP, and other complications

  6 months

Study Arms (2)

Conventional lipid-lowering therapy + Evolocumab group

EXPERIMENTAL

Drug: Evolocumab 140 MG/ML [Repatha]

Conventional lipid-lowering therapy group

ACTIVE COMPARATOR

Drug: Conventional lipid-lowering therapy

Interventions

Evolocumab 140 MG/ML [Repatha] DRUG

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.

Also known as: Dietary adjustments, Fibrates, Low-molecular-weight heparin, Insulin

Conventional lipid-lowering therapy + Evolocumab group

Conventional lipid-lowering therapy DRUG

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

Also known as: Dietary adjustments, Fibrates, Low-molecular-weight heparin, Insulin

Conventional lipid-lowering therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~75 years
• Patients with HTG-AP
• Mixed hyperlipidemia
• Sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

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

Shenyang, Liaoning, 110840, China

RECRUITING

Related Publications (15)

• Zengwu Wang, Jing Liu, Jianjun Li, et al. Chinese Guidelines for Lipid Management (2023). Chinese Journal of Circulation. 2023; 38 (03) : 237-271.

  BACKGROUND

• Wu BU, Johannes RS, Sun X, Tabak Y, Conwell DL, Banks PA. The early prediction of mortality in acute pancreatitis: a large population-based study. Gut. 2008 Dec;57(12):1698-703. doi: 10.1136/gut.2008.152702. Epub 2008 Jun 2.

  PMID: 18519429 BACKGROUND

• Ong Y, Shelat VG. Ranson score to stratify severity in Acute Pancreatitis remains valid - Old is gold. Expert Rev Gastroenterol Hepatol. 2021 Aug;15(8):865-877. doi: 10.1080/17474124.2021.1924058. Epub 2021 May 13.

  PMID: 33944648 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Qi R, Liu H, Li X, Chen M. Successful use of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Hypertriglyceridemia-induced Acute Pancreatitis: A Case Report. Curr Cardiol Rev. 2025;21(3):e1573403X343784. doi: 10.2174/011573403X343784241115055037.

  PMID: 39773061 BACKGROUND

• Chen H, Li X, Chen J, Zhao Y, Zhang W, Li H, Qi X. Lipid-lowering effect of evolocumab in hypertriglyceridemia-induced acute pancreatitis. Eur J Pharmacol. 2025 Nov 5;1006:178148. doi: 10.1016/j.ejphar.2025.178148. Epub 2025 Sep 16.

  PMID: 40967356 BACKGROUND

• Lu W, Wang L, Du C, Qin L, Li J, Wang H. PCSK9 Inhibitors in Multi-Branch Lesions in Coronary Artery Disease with Substandard Lipid-Lowering Effects. Altern Ther Health Med. 2024 Aug;30(8):356-360.

  PMID: 38064616 BACKGROUND

• Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1.

  PMID: 25282519 BACKGROUND

• Blom DJ, Hala T, Bolognese M, Lillestol MJ, Toth PD, Burgess L, Ceska R, Roth E, Koren MJ, Ballantyne CM, Monsalvo ML, Tsirtsonis K, Kim JB, Scott R, Wasserman SM, Stein EA; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809-19. doi: 10.1056/NEJMoa1316222. Epub 2014 Mar 29.

  PMID: 24678979 BACKGROUND

• Tan H, Li W, Huang Z, Han Y, Huang X, Li D, Xing X, Monsalvo ML, Wu Y, Mao J, Xin L, Chen J; HUA TUO study investigators. Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: 12-Week Primary Results of the HUA TUO Randomized Clinical Trial. Cardiol Ther. 2023 Jun;12(2):341-359. doi: 10.1007/s40119-023-00304-x. Epub 2023 Feb 21.

  PMID: 36802321 BACKGROUND

• Wiggins BS, Senfield J, Kassahun H, Lira A, Somaratne R. Evolocumab: Considerations for the Management of Hyperlipidemia. Curr Atheroscler Rep. 2018 Mar 6;20(4):17. doi: 10.1007/s11883-018-0720-3.

  PMID: 29511875 BACKGROUND

• Lu Z, Zhang G, Guo F, Li M, Ding Y, Zheng H, Wang D. Elevated triglycerides on admission positively correlate with the severity of hypertriglyceridaemic pancreatitis. Int J Clin Pract. 2020 Mar;74(3):e13458. doi: 10.1111/ijcp.13458. Epub 2019 Dec 14.

  PMID: 31799779 BACKGROUND

• Xin Hong, Liming Wang, Zhengliang Zhang, et al. Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis [J]. Chinese General Practice, 2021, 24(30): 3781-93

  BACKGROUND

• Na Zhang, Haiyan Zhang, Xiaohong Guo, et al. Meta-analysis of etiological changes of acute pancreatitis in China in the past Decade [J]. Chinese Journal of Gastroenterology and Imaging (Electronic Edition), 2016, 6(02): 71-5

  BACKGROUND

• Pancreatic Surgery Group, Surgical Branch of the Chinese Medical Association Chinese Guidelines for Diagnosis and Treatment of Acute Pancreatitis (2021) [J]. Chinese Journal of Digestive Surgery, 2021, 20(07): 730-9.

  BACKGROUND

MeSH Terms

Interventions

evolocumab; Fibric Acids; Heparin, Low-Molecular-Weight; Insulin

Intervention Hierarchy (Ancestors)

Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xingshun Qi

CONTACT

18909881019; xingshunqi@126.com

Yifan Guo

CONTACT

18341833373; guoyifan202402@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 5, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)