DRUG
Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions
Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss
Status
Not yet recruiting
Phase
Phase 4
Enrollment
72
Locations
0
Results
Not posted
Publications
0
Study 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.
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.
Interventions
DRUG
Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss
BEHAVIORAL
all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.
Timeline
First posted
Mar 7, 2025
Study start
May 1, 2025
Primary completion
Feb 1, 2027
Study completion
Feb 1, 2028
Results posted
Not reported
Registry updated
Mar 21, 2025
Outcomes
% 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
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
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
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)
% of body weight lost 1 year post op
Eligibility
Inclusion Criteria: \- 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 Exclusion Criteria: * 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
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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