Obesity, AdolescentPhase 4NCT06865365
Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
A Phase 4 study testing Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions and Dietologic measures and lifestyle optimization for weight loss in people with Obesity, Adolescent, run by Medical University of Vienna.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions and Dietologic measures and lifestyle optimization for weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seeking bariatric surgery
- 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
- Written informed consent
Who cannot join
- Patients with previous bariatric surgerys
- Patients aged below 18 years
- Patients with BMI < 35 kg/m2
- Patients with psychiatric disorders
- Patients not willing to adhere to preoperative dietological measures
- Patients with contraindications against Saxenda
- Patients who have health insurance other than Österreichische Gesundheitskasse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Moritz Felsenreich, Ap.Prof.Priv.-Doz.DDr. contact
About this study
Official title: Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
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.
Read the detailed description
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, 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.
After one year, the investigator will also check whether the weight loss has been maintained and whether the preoperative Saxenda continues to lose even more weight after the operation.
All patients looking for bariatric surgery with health insurance via Österreichische Gesundheitsklasse and BMI>35kg/m2 will be asked to take part in this study.
Patients with previous bariatric surgeries or contraindications against liraglutide will be excluded from this study.
- Conditions
- Obesity, Adolescent
- Being tested
- Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions, Dietologic measures and lifestyle optimization for weight loss
- Keywords
- Obesity, Bariatric surgery, metabolic surgery, liraglutide, saxenda, weight loss, surgery risk reduction, excess weight loss
- Medical subject headings
- Pediatric Obesity, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestionsDrug
Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss
Dietologic measures and lifestyle optimization for weight lossBehavioural
all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Control Group with only dietological measures | Active comparator | Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months Receives: Behavioral: Dietologic measures and lifestyle optimization for weight loss |
| Group B - Intervention with additional Liraglutide | Experimental | Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months Receives: Drug: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions |
What is being measured
The primary outcome is the main question the study is designed to answer.
% total weight loss
calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant
Measured: 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
Secondary outcomes (3)
comorbidities
The secondary parameter will be the prevalence of comorbidities (determined via use of pharmacological therapy therefore)
Measured: 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
hba1c
The secondary parameter will be hba1c in %
Measured: 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
% weight lost after one year
% of body weight lost 1 year post op
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, open
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moritz Felsenreich, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865365
- Sponsor's protocol ID
- 2493/2024
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
- ClinicalTrials.gov ID
- NCT06865365
- Acronym / sponsor ID
- 2493/2024
- Conditions
- Obesity, Adolescent
- Keywords
- Obesity, Bariatric surgery, metabolic surgery, liraglutide, saxenda, weight loss, surgery risk reduction, excess weight loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, 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.
After one year, the investigator will also check whether the weight loss has been maintained and whether the preoperative Saxenda continues to lose even more weight after the operation.
All patients looking for bariatric surgery with health insurance via Österreichische Gesundheitsklasse and BMI>35kg/m2 will be asked to take part in this study.
Patients with previous bariatric surgeries or contraindications against liraglutide will be excluded from this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, open
| Arm | Type | Receives |
|---|---|---|
| Group A - Control Group with only dietological measures | Active comparator | Behavioral: Dietologic measures and lifestyle optimization for weight lossPatients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months |
| Group B - Intervention with additional Liraglutide | Experimental | Drug: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestionsPatients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients seeking bariatric surgery
- 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
Key exclusion criteria (7 listed)
- Patients with previous bariatric surgerys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestionsLiraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss | Drug | Group B - Intervention with additional Liraglutide |
| Dietologic measures and lifestyle optimization for weight lossall subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively. | Behavioural | Group A - Control Group with only dietological measures |
Primary outcome
% 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
calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant
3 secondary outcomes
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
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
% 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moritz Felsenreich, Ap.Prof.Priv.-Doz.DDr. contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions and Dietologic measures and lifestyle optimization for weight loss in people with Obesity, Adolescent, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lea Pedarnig, MD (0043014040056210, lea.pedarnig@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.