NCT06865365

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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
22mo left

Started May 2025

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
May 2025Feb 2028

First Submitted

Initial submission to the registry

January 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

January 23, 2025

Last Update Submit

March 18, 2025

Conditions

Obesity, Adolescent

Keywords

ObesityBariatric surgerymetabolic surgeryliraglutidesaxendaweight losssurgery risk reductionexcess weight loss

Outcome Measures

Primary Outcomes (1)

  • % total weight loss

    calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant

    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 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 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

    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)

Study Arms (2)

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

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

Drug: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions

Interventions

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

Group B - Intervention with additional Liraglutide
Dietologic measures and lifestyle optimization for weight lossBEHAVIORAL

all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.

Group A - Control Group with only dietological measures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric ObesityObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Central Study Contacts

Lea Pedarnig, MD

CONTACT

0043014040056210lea.pedarnig@meduniwien.ac.at

Moritz Felsenreich, Ap.Prof.Priv.-Doz.DDr.

CONTACT

0043014040056210moritz.felsenreich@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial, open
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Ap. Prof. Priv. Doz. DDr. )

Study Record Dates

First Submitted

January 23, 2025

First Posted

March 7, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share