GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis

NCT07617155 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-RECAP-GLP1
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 18 months after randomization

Secondary Outcomes (14)

• Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes

  18 months after randomization

• Change in fasting serum triglyceride level

  Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

• Change in PAN-PROMISE score

  Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

• Change in lipid profile parameters

  Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

• Change in glycemic parameters

  Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

Study Arms (2)

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.

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.

Drug: Placebo (Normal Saline)

Interventions

Semaglutide DRUG

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.

Also known as: Ozempic, Wegovy

Semaglutide

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• The ability to understand the trial and completing it, as evaluated by the investigators.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

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MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic; Hypertriglyceridemia

Interventions

semaglutide; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Dong Wu, Medical Doctor

CONTACT

8618612671010; dongwu@pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)