← Human Trials & Peer-Reviewed Studies

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.