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Hypertriglyceridemia Induced Acute PancreatitisNCT07388420

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

A study testing Evolocumab 140 MG/ML [Repatha] and Conventional lipid-lowering therapy in people with Hypertriglyceridemia Induced Acute Pancreatitis, run by General Hospital of Shenyang Military Region at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Evolocumab 140 MG/ML [Repatha] and Conventional lipid-lowering therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
2 Jan 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

    Shenyang, Liaoning, 110840

    Xingshun Qi, 18909881019, xingshunqi@126.com

    Yifan Guo, 18341833373, guoyifan202402@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

Overall, 60 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.

Being tested
Evolocumab 140 MG/ML [Repatha], Conventional lipid-lowering therapy
Keywords
Hypertriglyceridemia Induced Acute Pancreatitis, Evolocumab, Conventional lipid-lowering therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evolocumab 140 MG/ML [Repatha]Drug

    Also called Dietary adjustments, Fibrates, Low-molecular-weight heparin, Insulin

    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 therapyDrug

    Also called Dietary adjustments, Fibrates, Low-molecular-weight heparin, Insulin

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

Study groups in NCT07388420
Study groupRoleWhat they receive
Conventional lipid-lowering therapy + Evolocumab groupExperimentalNot described
Receives: Drug: Evolocumab 140 MG/ML [Repatha]
Conventional lipid-lowering therapy groupActive comparatorNot described
Receives: Drug: Conventional lipid-lowering therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The TG levels on the 3rd and 7th days after treatment

    Measured: 3 days and 7days

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

    Measured: 3 days and 7 days

Secondary outcomes (2)
  1. The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment

    Measured: 3 days and 7days

  2. The incidence of RAP, SAP, and other complications

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start2 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388420
Sponsor's protocol ID
XHNKKY-HTGAP
Status last verified
Jan 2026
First submitted
21 Jan 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 18519429
  • 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.

    PubMed 33944648
  • 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.

    PubMed 23100216
  • 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.

    PubMed 39773061
  • 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.

    PubMed 40967356
  • 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.

    PubMed 38064616
  • 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.

    PubMed 25282519
  • 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.

    PubMed 24678979
  • 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.

    PubMed 36802321
  • 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.

    PubMed 29511875
  • 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.

    PubMed 31799779
  • 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

  • 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

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Evolocumab 140 MG/ML [Repatha] and Conventional lipid-lowering therapy in people with Hypertriglyceridemia Induced Acute Pancreatitis, run by General Hospital of Shenyang Military Region at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xingshun Qi (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The TG levels on the 3rd and 7th days after treatment (time frame: 3 days and 7days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07388420, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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