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Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)

Plain-language guide to NCT03371862: phase 2 interventional trial of Liraglutide. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03371862
Phase
phase 2
Status
withdrawn
Start
2017-10-20
Completion (planned or actual)
2020-08-06
Participants
n/a (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Short Bowel Syndrome
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Liraglutide.

It had 1 arm (groups): Test group (experimental).

The registry classes the interventions as drug.

Who Took Part

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: Short bowel (≤200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn's disease). Jejunostomy patients only. 12 continuous months of parenteral support (PS) dependency prior to enrolment. PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption. Actual PS usage should match prescribed PS;.

The full record lists 14 inclusion and 20 exclusion criteria; among the exclusions: patients \< 18 years of age; active malignancy; previous malignancy within the past 5 years.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-10-20 with completion listed for 2020-08-06.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Duration of response, Days/Nights not requiring PS and Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Liraglutide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

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.