A Trial to Evaluate Safety, Feasibility and Efficacy of Endoscopic Duodenal PEF Therapy

What Was Tested

The trial (not phased) is built around Semaglutide.

It had two arms (groups): PEF therapy procedure (active comparator) and Sham procedure (sham comparator).

The registry classes the interventions as device, drug and other.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 28 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with type 2 diabetes mellitus. 28 - 75 years of age. BMI ≥ 24 and ≤ 42 kg/m2. Willing to comply with study requirements and able to understand and comply with signed informed consent.

The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: diagnosed with type 1 diabetes or with a history of ketoacidosis; current or within the last 3 months use of a glp-1 analogue; history of chronic or acute pancreatitis.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-08-03 with completion listed for 2025-03-21.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety] (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example Secondary safety endpoint 1 - hypoglycemic events, Secondary safety endpoint 2 - SAEs, Secondary feasibility endpoint 1 - technical success rate, Secondary feasibility endpoint 2 - GLP-1RA tolerability and Secondary efficay endpoint 1 - HbA1c 48 weeks.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.