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Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

Plain-language guide to NCT06865365: phase 4 randomized trial of Liraglutide, 72 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06865365
Phase
phase 4
Status
not yet recruiting
Start
2025-05-01
Completion (planned or actual)
2027-02-01
Participants
72 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Obesity, Adolescent
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Liraglutide.

The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide).

There are two groups, one group receives Saxena in addition to dietary measures when first seeking the operation, one group only diet.

The investigator is researching how much additional preoperative weight loss is possible with the drug admitted preoperatively.

It had two arms (groups): Group A - Control Group with only dietological measures (active comparator) and Group B - Intervention with additional Liraglutide (experimental).

Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months.

Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months.

The registry classes the interventions as behavioral and drug.

More on the Plan

There are two groups, one group receives Saxena in addition to dietary measures, one group only diet.

Each group will have a waiting period of 6 months until the operation will be done.

The investigator wants to elaborate how much additional preoperative weight loss is possible with the drug.

The greater the preoperative weight loss, the lower the risk of the operation.

Who Took Part

Enrollment: 72 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: BMI \> 35.0 kg/m2. Health insurance via Österreichische Gesundheitskasse. Willingness to be assigned to either of the two groups. Willingness to adhere to preoperative dietological measures. Follow-up anticipation with blood draws and body weight scans using Secca scale.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: patients with previous bariatric surgerys; patients aged below 18 years; patients with bmi \< 35 kg/m2.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2025-05-01 with completion listed for 2027-02-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: % total weight loss.

It also tracked 3 secondary outcomes, for example comorbidities, hba1c and % weight lost after one year.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 72 people.

Its status is not yet recruiting; 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.