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RECAP-GLP1
Not yet recruitingPhase 4GLP-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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
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
Glycemic / diabetes
1 endpointChange in glycemic parameters
Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
change from baseline, improvement
MASH / liver
1 endpointMRI 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 endpointsChange in fasting serum triglyceride level
Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
change from baseline, improvement
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 endpointChange in health-related quality of life
Time frame:Baseline and 18 months after randomization
change from baseline, improvement
Other clinical outcomes
3 endpointsIncidence of metabolic and pancreatic complications
Time frame:Within 18 months after randomization
event count, event
Incidence of chronic pancreatitis
Time frame:18 months after randomization
event count, event
All-cause mortality
Time frame:18 months after randomization
descriptive
Other (unclassified)
7 endpointsProportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Time frame:Within 18 months after randomization
threshold achievement, improvement
Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Time frame:18 months after randomization
event count, event
Change in PAN-PROMISE score
Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
change from baseline, improvement
Change in anthropometric measures
Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
change from baseline, improvement
Change in smoking
Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
change from baseline, improvement
Change in alcohol consumption
Time frame:Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
change from baseline, improvement
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
- Science China. Life sciences2025 Oct (month)PMID40550999doi:10.1007/s11427-024-2900-6via CT.gov background
- Diabetes & metabolic syndrome2024 Sep (month)PMID39332263doi:10.1016/j.dsx.2024.103116via CT.gov background
- Obesity reviews : an official journal of the International Association for the Study of Obesity2024 Jun (month)PMID38346789doi:10.1111/obr.13725via CT.gov background
- The American journal of emergency medicine2024 Apr (month)PMID38241775doi:10.1016/j.ajem.2024.01.010via CT.gov background
- Journal of clinical lipidology2023 Jan-Feb (year)PMID36697323doi:10.1016/j.jacl.2022.11.006via CT.gov background
- JAMA internal medicine2022 May 1PMID35344001doi:10.1001/jamainternmed.2022.0338via CT.gov background
- Frontiers in endocrinology2022 (year)PMID36568085doi:10.3389/fendo.2022.1043789via CT.gov background
- The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov background
- Diabetes, obesity & metabolism2020 Apr (month)PMID31750601doi:10.1111/dom.13924via CT.gov background
- Diabetes research and clinical practice2020 Mar (month)PMID32084455doi:10.1016/j.diabres.2020.108087via CT.gov background
- Digestive diseases and sciences2019 Mar (month)PMID30094622doi:10.1007/s10620-018-5226-xvia CT.gov background
- Clinical journal of gastroenterology2018 Dec (month)PMID29923163doi:10.1007/s12328-018-0881-1via CT.gov background
- Diabetes, obesity & metabolism2018 Mar (month)PMID28941314doi:10.1111/dom.13120via CT.gov background
- Diabetes, obesity & metabolism2017 Sep (month)PMID28244632doi:10.1111/dom.12926via CT.gov background
- Journal of clinical gastroenterology2017 Aug (month)PMID28682990doi:10.1097/MCG.0000000000000846via CT.gov background
- Journal of clinical gastroenterology2017 Jan (month)PMID27322530doi:10.1097/MCG.0000000000000579via CT.gov background
- European journal of internal medicine2015 Sep (month)PMID26143191doi:10.1016/j.ejim.2015.06.013via CT.gov background
- The New England journal of medicine2015 Jul 2PMID26132939doi:10.1056/NEJMoa1411892via CT.gov background
- European journal of internal medicine2014 Oct (month)PMID25269432doi:10.1016/j.ejim.2014.08.008via CT.gov background
- Journal of clinical gastroenterology2014 Mar (month)PMID24172179doi:10.1097/01.mcg.0000436438.60145.5avia CT.gov background
- JAMA internal medicine2013 Apr 8PMID23440284doi:10.1001/jamainternmed.2013.2720via CT.gov background
- Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2011 Dec (month)PMID21479777doi:10.1007/s11136-011-9903-xvia CT.gov background
Role of incretin hormones in the regulation of insulin secretion in diabetic and nondiabetic humans.
American journal of physiology. Endocrinology and metabolism2004 Aug (month)PMID15271645doi:10.1152/ajpendo.00545.2003via CT.gov background- 2000 (year)PMID29989767via CT.gov background
- The American journal of clinical nutrition1999 Apr (month)PMID10197564doi:10.1093/ajcn/69.4.632via CT.gov background
- The American journal of physiology1997 Nov (month)PMID9374685doi:10.1152/ajpendo.1997.273.5.E981via CT.gov background
Provenance
Sources
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.