Trial · Interventional
Not yet recruitingPhase 4Registry dataPreoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 72 participants (estimated)
- Sponsor
- Medical University of Vienna · Other
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- 1 May 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Mar 2025
- Last update posted
- 21 Mar 2025
- Conditions
- Obesity, Adolescent
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
NCT06865365est. 1 May 2025 to est. 1 Feb 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestionsDrug
- Dietologic measures and lifestyle optimization for weight lossBehavioral
Arms2
Active comparator
Group A - Control Group with only dietological measures
Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months
Experimental
Group B - Intervention with additional Liraglutide
Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months
Primary outcomes1
Outcomes the sponsor listed as primary.
% total weight loss
Time frame · body weight and bmi will be assessed immediately when admission to the study is done as reference value and at at time of operation, which is 6 months after admission to the study, as outcome value
Registry description
calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant
Secondary outcomes(3)
comorbidities
Time frame · The secondary parameters will be assessed immediately at the time when admission to the study is done for reference and the time of the surgery, which is 6 months after admission, as outcome parameter
Registry description
The secondary parameter will be the prevalence of comorbidities (determined via use of pharmacological therapy therefore)
hba1c
Time frame · The secondary parameters will be assessed immediately when admission to the study is done for reference and the time of the surgery, which is 6 months after admission, as outcome parameter
Registry description
The secondary parameter will be hba1c in %
% weight lost after one year
Time frame · Body weight will be assessed immediately when admission to the study is done and the time of the surgery (=6 months after admission) and 1 year post op (=18 months after admission)
Registry description
% of body weight lost 1 year post op
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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