Hypertriglyceridemia Induced Acute PancreatitisPhase 4RECAP-GLP1NCT07617155
GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis
A Phase 4 study testing Semaglutide in people with Hypertriglyceridemia Induced Acute Pancreatitis and Recurrent Acute Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is associated with a high risk of recurrence despite standard lipid-lowering therapy and lifestyle modification. The goal of this clinical trial is to evaluate whether GLP-1 receptor agonist therapy can reduce the recurrence of HTG-AP in adults with a history of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia Induced Acute Pancreatitis, Recurrent Acute Pancreatitis, Pancreatitis Relapsing
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Previous diagnosis of index HTG-AP (defined as AP with serum TG >1000 mg/dL or a serum TG level of 500-1000 mg/dL accompanied by chylous serum)36-38
- Having HTG as the exclusive cause of AP
- Time from discharge of index HTG-AP to recruitment between 4 weeks to 3 months, without AP-related symptoms between discharge and recruitment
- Expression of the willingness to comply with lifestyle modification during the study period.
- Clinically stable at the time of inclusion
Show all 22Show fewer
- The ability to understand the trial and completing it, as evaluated by the investigators.
- Patients who may get pregnant should ensure using contraceptives for 20 months after inclusion Exclusion Criteria
- History of malignancy in past 5 years
- History of hypothyroidism, nephrotic syndrome, Cushing's syndrome or AIDS
- History of chronic pancreatitis or pancreatic neoplasm
- History of severe cardiovascular and pulmonary diseases, such as heart failure, coronary heart disease and chronic obstructive pulmonary disease.
- Severe renal deficiency (glomerular filtration rate < 30 ml/min)
- Severe hepatic deficiency (Child-Pugh Class B or C)
- Previous pancreatic surgery
- Recurrent AP due to pancreatic diverticulum
- Recurrent AP due to known genetic mutations (eg. CFTR)
- Personal or family history of medullary thyroid carcinoma (MTC)
- Current or prior diagnosis or suspected diagnosis of multiple endocrine neoplasia type 2 (MEN2)
- Serious hypersensitivity reaction to semaglutide or any of the excipients in the investigational drug or placebo
- Pregnancy
- Breast-feeding
Who cannot join
None listed.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dong Wu, Medical Doctor, 8618612671010, dongwu@pumc.edu.cn
About this study
Official title: Effects of GLP-1 Agonists on Prevention of HTG-Induced Acute Pancreatitis Recurrence: Protocol for a Randomized Clinical Trial
Hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is associated with a high risk of recurrence despite standard lipid-lowering therapy and lifestyle modification. The goal of this clinical trial is to evaluate whether GLP-1 receptor agonist therapy can reduce the recurrence of HTG-AP in adults with a history of HTG-AP and hypertriglyceridemia.
The main questions this study aims to answer are:
Read more
- Whether GLP-1 receptor agonist therapy reduces the recurrence rate of HTG-AP.
- Whether GLP-1 receptor agonist therapy improves triglyceride control, body weight, and metabolic parameters.
- Whether GLP-1 receptor agonist therapy is safe and well tolerated in this patient population.
Researchers will compare GLP-1 receptor agonist therapy plus standard care with standard care alone to determine whether GLP-1 receptor agonist therapy provides additional benefit in preventing recurrent HTG-AP.
Participants will:
- Receive either GLP-1 receptor agonist therapy plus standard care or standard care alone.
- Undergo regular clinical follow-up visits and laboratory assessments.
- Receive monitoring of triglyceride levels, recurrence events, metabolic outcomes, and adverse events during the study period.
- Conditions
- Hypertriglyceridemia Induced Acute Pancreatitis, Recurrent Acute Pancreatitis, Pancreatitis Relapsing, Hypertriglyceridemia
- Being tested
- Semaglutide, Placebo (Normal Saline)
- Keywords
- hypertriglyceridemia-induced acute pancreatitis, recurrent acute pancreatitis, semaglutide, GLP-1 receptor agonist, pancreatitis prevention
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic, Wegovy
Semaglutide is administered as a once-weekly subcutaneous injection for 18 months. Treatment is initiated at 0.25 mg once weekly for the first 4 weeks and escalated to 0.5 mg once weekly thereafter to improve tolerability.
Placebo (Normal Saline)Drug
Placebo consists of normal saline administered as a once-weekly subcutaneous injection following the same administration schedule as semaglutide for 18 months. Participants receive 0.25 mg-equivalent injection volume once weekly for the first 4 weeks followed by 0.5 mg-equivalent injection volume once weekly thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants receive once-weekly subcutaneous semaglutide for 18 months. Semaglutide is initiated at 0.25 mg weekly for 4 weeks and escalated to 0.5 mg weekly thereafter. Participants also receive standard-of-care management and lifestyle modification counseling, including low-fat diet, physical activity, weight management, smoking cessation, and alcohol limitation. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants receive once-weekly matching placebo (normal saline) subcutaneous injections for 18 months following the same administration schedule as the experimental arm. Participants also receive standard-of-care management and lifestyle modification counseling, including low-fat diet, physical activity, weight management, smoking cessation, and alcohol limitation. Receives: Drug: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Recurrent hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is defined as an episode of acute pancreatitis occurring at least 1 month after complete symptom resolution from the index episode, with serum triglycerides >1000 mg/dL or triglycerides 500-1000 mg/dL accompanied by chylous serum and no other identifiable cause of acute pancreatitis.
Measured: Within 18 months after randomization
Secondary outcomes (14)
Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Total number of recurrent HTG-AP episodes experienced by each participant during follow-up.
Measured: 18 months after randomization
Change in fasting serum triglyceride level
Change in fasting serum triglyceride concentration from baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in PAN-PROMISE score
Change in patient-reported outcomes measured using the PAN-PROMISE questionnaire. PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, (PAN-PROMISE scale) was designed and validated to evaluate the symptoms that cause the greatest discomfort and concern to patients with AP. They include pain, abdominal distension, difficulty eating, difficulty with bowel movements, nausea or vomiting, thirst, and weakness. Each symptom is scored (highest intensity in the last 24 hours) by the patient from 0 (none) to 10 (maximum possible intensity according to the patient's judgment), with a total score ranging from 0 to 70.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in lipid profile parameters
Changes in total cholesterol, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) from baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in glycemic parameters
Changes in fasting serum glucose and hemoglobin A1C from baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in anthropometric measures
Changes in body weight, body mass index (BMI), and waist circumference from baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in smoking
Changes in self-reported smoking amount
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in alcohol consumption
Changes in self-reported alcohol intake from baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
MRI assessment of hepatic and pancreatic fat infiltration and pancreatic volume
Changes in MRI-based measurements of hepatic fat infiltration, pancreatic fat infiltration, and pancreatic volume from baseline.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Incidence of metabolic and pancreatic complications
Incidence of stress hyperglycemia, post-acute pancreatitis diabetes mellitus, abdominal obesity, or pancreatic exocrine insufficiency.
Measured: Within 18 months after randomization
Incidence of chronic pancreatitis
Incidence of newly diagnosed chronic pancreatitis during follow-up.
Measured: 18 months after randomization
Change in health-related quality of life
Change in EQ-VAS score from baseline. EQ VAS is a 0-100 scale where respondents are asked to indicate their overall health on the day they complete the questionnaire. It is a visual analog scale. The score ranges from 0 to 100 where 100 means the best health the patient can imagine, and 0 means the worst health the patient can imagine.
Measured: Baseline and 18 months after randomization
Pancreatitis-related unplanned readmission rate
Rate of unplanned hospital readmissions related to pancreatitis.
Measured: 18 months after randomization
All-cause mortality
Death from any cause during study follow-up.
Measured: 18 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Hypertriglyceridemia Induced Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG WU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617155
- Sponsor's protocol ID
- 2026-RECAP-GLP1
- Acronym
- RECAP-GLP1
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
PubMed 32245906Xu X, Ding L, Chen T, Liu G, Deng L, Sheng J, Zhu C, Sheng J, Zhang H, Wu D, He W, Xia L, Luo L, Xiong H, Lu NH, Ke L, Zhu Y; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Efficacy and safety of intensive triglyceride-lowering therapy on reducing recurrence of hypertriglyceridemia-associated pancreatitis (REDUCE): protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 Jul 18;15(7):e093011. doi: 10.1136/bmjopen-2024-093011.
PubMed 40681200Wang Q, Wang G, Qiu Z, He X, Liu C. Elevated Serum Triglycerides in the Prognostic Assessment of Acute Pancreatitis: A Systematic Review and Meta-Analysis of Observational Studies. J Clin Gastroenterol. 2017 Aug;51(7):586-593. doi: 10.1097/MCG.0000000000000846.
PubMed 28682990Scherer J, Singh VP, Pitchumoni CS, Yadav D. Issues in hypertriglyceridemic pancreatitis: an update. J Clin Gastroenterol. 2014 Mar;48(3):195-203. doi: 10.1097/01.mcg.0000436438.60145.5a.
PubMed 24172179Trikudanathan G, Yazici C, Evans Phillips A, Forsmark CE. Diagnosis and Management of Acute Pancreatitis. Gastroenterology. 2024 Sep;167(4):673-688. doi: 10.1053/j.gastro.2024.02.052. Epub 2024 May 15.
PubMed 38759844Tsai MS, Lin CL, Hsu YC, Lee HM, Kao CH. Long-term risk of pancreatitis and diabetes after cholecystectomy in patients with cholelithiasis but no pancreatitis history: a 13-year follow-up study. Eur J Intern Med. 2015 Sep;26(7):540-4. doi: 10.1016/j.ejim.2015.06.013. Epub 2015 Jul 2.
PubMed 26143191Nreu B, Dicembrini I, Tinti F, Mannucci E, Monami M. Cholelithiasis in patients treated with Glucagon-Like Peptide-1 Receptor: An updated meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2020 Mar;161:108087. doi: 10.1016/j.diabres.2020.108087. Epub 2020 Feb 19.
PubMed 32084455Yang W, Wu H, Cai X, Lin C, Luo Y, Hu S, Li Z, Jiao R, Bai S, Liu G, Yang X, Ji L. Weight reduction and the risk of gallbladder and biliary disease: A systematic review and meta-analysis of randomized clinical trials. Obes Rev. 2024 Jun;25(6):e13725. doi: 10.1111/obr.13725. Epub 2024 Feb 12.
PubMed 38346789He L, Wang J, Ping F, Yang N, Huang J, Li Y, Xu L, Li W, Zhang H. Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2022 May 1;182(5):513-519. doi: 10.1001/jamainternmed.2022.0338.
PubMed 35344001Smits MM, Van Raalte DH. Safety of Semaglutide. Front Endocrinol (Lausanne). 2021 Jul 7;12:645563. doi: 10.3389/fendo.2021.645563. eCollection 2021.
PubMed 34305810Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013 Apr 8;173(7):534-9. doi: 10.1001/jamainternmed.2013.2720.
PubMed 23440284Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M. Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. JAMA. 2023 Nov 14;330(18):1795-1797. doi: 10.1001/jama.2023.19574.
PubMed 37796527Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
PubMed 28473337Steinberg WM, Buse JB, Ghorbani MLM, Orsted DD, Nauck MA; LEADER Steering Committee; LEADER Trial Investigators. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Diabetes Care. 2017 Jul;40(7):966-972. doi: 10.2337/dc16-2747. Epub 2017 May 5.
PubMed 28476871
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Agonists on Prevention of HTG-Induced Acute Pancreatitis Recurrence: Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07617155
- Acronym / sponsor ID
- RECAP-GLP1 / 2026-RECAP-GLP1
- Conditions
- Hypertriglyceridemia Induced Acute Pancreatitis, Recurrent Acute Pancreatitis, Pancreatitis Relapsing, Hypertriglyceridemia
- Keywords
- hypertriglyceridemia-induced acute pancreatitis, recurrent acute pancreatitis, semaglutide, GLP-1 receptor agonist, pancreatitis prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is associated with a high risk of recurrence despite standard lipid-lowering therapy and lifestyle modification. The goal of this clinical trial is to evaluate whether GLP-1 receptor agonist therapy can reduce the recurrence of HTG-AP in adults with a history of HTG-AP and hypertriglyceridemia.
The main questions this study aims to answer are:
- Whether GLP-1 receptor agonist therapy reduces the recurrence rate of HTG-AP.
- Whether GLP-1 receptor agonist therapy improves triglyceride control, body weight, and metabolic parameters.
- Whether GLP-1 receptor agonist therapy is safe and well tolerated in this patient population.
Researchers will compare GLP-1 receptor agonist therapy plus standard care with standard care alone to determine whether GLP-1 receptor agonist therapy provides additional benefit in preventing recurrent HTG-AP.
Participants will:
- Receive either GLP-1 receptor agonist therapy plus standard care or standard care alone.
- Undergo regular clinical follow-up visits and laboratory assessments.
- Receive monitoring of triglyceride levels, recurrence events, metabolic outcomes, and adverse events during the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants receive once-weekly subcutaneous semaglutide for 18 months. Semaglutide is initiated at 0.25 mg weekly for 4 weeks and escalated to 0.5 mg weekly thereafter. Participants also receive standard-of-care management and lifestyle modification counseling, including low-fat diet, physical activity, weight management, smoking cessation, and alcohol limitation. |
| Placebo | Placebo comparator | Drug: Placebo (Normal Saline)Participants receive once-weekly matching placebo (normal saline) subcutaneous injections for 18 months following the same administration schedule as the experimental arm. Participants also receive standard-of-care management and lifestyle modification counseling, including low-fat diet, physical activity, weight management, smoking cessation, and alcohol limitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years old
- Previous diagnosis of index HTG-AP (defined as AP with serum TG >1000 mg/dL or a serum TG level of 500-1000 mg/dL accompanied by chylous serum)36-38
- Having HTG as the exclusive cause of AP
- Time from discharge of index HTG-AP to recruitment between 4 weeks to 3 months, without AP-related symptoms between discharge and recruitment
- Expression of the willingness to comply with lifestyle modification during the study period.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Ozempic, WegovySemaglutide is administered as a once-weekly subcutaneous injection for 18 months. Treatment is initiated at 0.25 mg once weekly for the first 4 weeks and escalated to 0.5 mg once weekly thereafter to improve tolerability. | Drug | Semaglutide |
| Placebo (Normal Saline)Placebo consists of normal saline administered as a once-weekly subcutaneous injection following the same administration schedule as semaglutide for 18 months. Participants receive 0.25 mg-equivalent injection volume once weekly for the first 4 weeks followed by 0.5 mg-equivalent injection volume once weekly thereafter. | Drug | Placebo |
Primary outcome
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Time frame: Within 18 months after randomization
Recurrent hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is defined as an episode of acute pancreatitis occurring at least 1 month after complete symptom resolution from the index episode, with serum triglycerides >1000 mg/dL or triglycerides 500-1000 mg/dL accompanied by chylous serum and no other identifiable cause of acute pancreatitis.
14 secondary outcomes
Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Time frame: 18 months after randomization
Change in fasting serum triglyceride level
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in PAN-PROMISE score
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in lipid profile parameters
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in glycemic parameters
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in anthropometric measures
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in smoking
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in alcohol consumption
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
MRI assessment of hepatic and pancreatic fat infiltration and pancreatic volume
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Incidence of metabolic and pancreatic complications
Time frame: Within 18 months after randomization
Incidence of chronic pancreatitis
Time frame: 18 months after randomization
Change in health-related quality of life
Time frame: Baseline and 18 months after randomization
Pancreatitis-related unplanned readmission rate
Time frame: 18 months after randomization
All-cause mortality
Time frame: 18 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 32245906de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
- Background: PubMed 40681200Xu X, Ding L, Chen T, Liu G, Deng L, Sheng J, Zhu C, Sheng J, Zhang H, Wu D, He W, Xia L, Luo L, Xiong H, Lu NH, Ke L, Zhu Y; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Efficacy and safety of intensive triglyceride-lowering therapy on reducing recurrence of hypertriglyceridemia-associated pancreatitis (REDUCE): protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 Jul 18;15(7):e093011. doi: 10.1136/bmjopen-2024-093011.
- Background: PubMed 28682990Wang Q, Wang G, Qiu Z, He X, Liu C. Elevated Serum Triglycerides in the Prognostic Assessment of Acute Pancreatitis: A Systematic Review and Meta-Analysis of Observational Studies. J Clin Gastroenterol. 2017 Aug;51(7):586-593. doi: 10.1097/MCG.0000000000000846.
- Background: PubMed 24172179Scherer J, Singh VP, Pitchumoni CS, Yadav D. Issues in hypertriglyceridemic pancreatitis: an update. J Clin Gastroenterol. 2014 Mar;48(3):195-203. doi: 10.1097/01.mcg.0000436438.60145.5a.
- Background: PubMed 38759844Trikudanathan G, Yazici C, Evans Phillips A, Forsmark CE. Diagnosis and Management of Acute Pancreatitis. Gastroenterology. 2024 Sep;167(4):673-688. doi: 10.1053/j.gastro.2024.02.052. Epub 2024 May 15.
- Background: PubMed 26143191Tsai MS, Lin CL, Hsu YC, Lee HM, Kao CH. Long-term risk of pancreatitis and diabetes after cholecystectomy in patients with cholelithiasis but no pancreatitis history: a 13-year follow-up study. Eur J Intern Med. 2015 Sep;26(7):540-4. doi: 10.1016/j.ejim.2015.06.013. Epub 2015 Jul 2.
- Background: PubMed 32084455Nreu B, Dicembrini I, Tinti F, Mannucci E, Monami M. Cholelithiasis in patients treated with Glucagon-Like Peptide-1 Receptor: An updated meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2020 Mar;161:108087. doi: 10.1016/j.diabres.2020.108087. Epub 2020 Feb 19.
- Background: PubMed 38346789Yang W, Wu H, Cai X, Lin C, Luo Y, Hu S, Li Z, Jiao R, Bai S, Liu G, Yang X, Ji L. Weight reduction and the risk of gallbladder and biliary disease: A systematic review and meta-analysis of randomized clinical trials. Obes Rev. 2024 Jun;25(6):e13725. doi: 10.1111/obr.13725. Epub 2024 Feb 12.
- Background: PubMed 35344001He L, Wang J, Ping F, Yang N, Huang J, Li Y, Xu L, Li W, Zhang H. Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2022 May 1;182(5):513-519. doi: 10.1001/jamainternmed.2022.0338.
- Background: PubMed 34305810Smits MM, Van Raalte DH. Safety of Semaglutide. Front Endocrinol (Lausanne). 2021 Jul 7;12:645563. doi: 10.3389/fendo.2021.645563. eCollection 2021.
- Background: PubMed 23440284Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013 Apr 8;173(7):534-9. doi: 10.1001/jamainternmed.2013.2720.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Hypertriglyceridemia Induced Acute Pancreatitis and Recurrent Acute Pancreatitis, run by Peking Union Medical College Hospital 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 22 inclusion and 0 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: opening soon, as of the sponsor's last update on 1 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dong Wu, Medical Doctor (8618612671010, dongwu@pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis (time frame: Within 18 months after randomization). 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 NCT07617155, which also lists 39 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 1 Jun 2026.