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GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis
Plain-language guide to NCT07617155: phase 4 randomized trial of Semaglutide, 396 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07617155
- Phase
- phase 4
- Status
- not yet recruiting
- Start
- 2026-09
- Completion (planned or actual)
- 2028-09
- Participants
- 396 (estimated)
- Design
- randomized, quadruple-blind, prevention
- Conditions studied
- Hypertriglyceridemia Induced Acute Pancreatitis; Recurrent Acute Pancreatitis; Pancreatitis Relapsing; Hypertriglyceridemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Semaglutide.
It had two arms (groups): Semaglutide (experimental) and 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.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 396 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥ 18 years old. 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 full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: history of malignancy in past 5 years; history of hypothyroidism, nephrotic syndrome, cushing's syndrome or aids; history of chronic pancreatitis or pancreatic neoplasm.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2026-09 with completion listed for 2028-09.
It ran at 1 site in China.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis (time frame: Within 18 months after randomization).
It also tracked 14 secondary outcomes, for example Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes, Change in fasting serum triglyceride level, Change in PAN-PROMISE score, Change in lipid profile parameters, Change in glycemic parameters and Change in anthropometric measures.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Semaglutide in 396 people.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.