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NCT Number: NCT06865365

Preoperative Use of 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.

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Key information

Conditions

Obesity, Adolescent Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss

Dietologic measures and lifestyle optimization for weight loss

Behavioral

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

Primary outcomes

  1. % 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

Secondary outcomes

  1. 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)

  2. 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 %

  3. % 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lea Pedarnig, MD

CONTACT

[email protected]

0043014040056210

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

CONTACT

[email protected]

0043014040056210

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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