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RECAP-GLP1

Not yet recruitingPhase 4

GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis

Effects of GLP-1 Agonists on Prevention of HTG-Induced Acute Pancreatitis Recurrence: Protocol for a Randomized Clinical Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

396

estimated

Study population

Dyslipidemia, Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Key I/E criterion

Primary endpoint

Recurrent hypertriglyceridemia-induced acute pancreatitis

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07617155
Org study ID2026-RECAP-GLP1

Timeline

Milestones

Study first posted2026-06-01actual
Last update posted2026-06-01actual
Study start2026-09estimated (month precision)
Primary completion2028-09estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

DyslipidemiaGastrointestinal (gastroparesis / short bowel / pancreatitis)

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

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
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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
7
Other clinical outcomes
3
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
MASH / liver
1
Patient-reported / QoL
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in glycemic parameters

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

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

ratio, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in fasting serum triglyceride level

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change in lipid profile parameters

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in health-related quality of life

Time frame:Baseline and 18 months after randomization

change from baseline, improvement

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint

Incidence of metabolic and pancreatic complications

Time frame:Within 18 months after randomization

event count, event

Secondary/protocol endpoint

Incidence of chronic pancreatitis

Time frame:18 months after randomization

event count, event

Secondary/protocol endpoint

All-cause mortality

Time frame:18 months after randomization

descriptive

Other (unclassified)

7 endpoints
Primary/protocol endpoint/low confidence

Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis

Time frame:Within 18 months after randomization

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes

Time frame:18 months after randomization

event count, event

Secondary/protocol endpoint/low confidence

Change in PAN-PROMISE score

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in anthropometric measures

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in smoking

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in alcohol consumption

Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Pancreatitis-related unplanned readmission rate

Time frame:18 months after randomization

descriptive

Publications (39)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.