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Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon Liraglutid
Plain-language guide to NCT02417103: phase 3 randomized trial of Liraglutide, 2 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02417103
- Phase
- phase 3
- Status
- terminated early
- Start
- 2011-12
- Completion (planned or actual)
- 2016-09
- Participants
- 2 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Liraglutide.
The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.
It had two arms (groups): GLP-1 (Liraglutide) (active comparator) and Placebo Comparator (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 2 actual participants took part.
It was open to people of any sex aged from 18 years up to 77 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: BMI 35-55 Kg/m2. Planned bariatric surgery. Diabetic Medication (Metformin, Sulfonylurea, Insuline).
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known hypersensitivity against liraglutid; pretreatment dpp-4 inhibitors or glp-1 analogue the last 3 months.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 Liraglutide.
Those kept unaware of assignments: participant and care provider.
It started in 2011-12 with completion listed for 2016-09.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example GLP-1 Levels.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 2 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.