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NCT Number: NCT06287307

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

The treatment of obesity can be divided into three different fields: non-surgical interventions (e.g. endoscopic techniques, swallowable gastric balloon), pharmacological, and surgical treatment. All these different fields have, as their cornerstone of treatment, lifestyle interventions. Lifestyle interventions have an emphasis on regulation of energy intake and improvement of physical activity. All treatment options are adjunct to the lifestyle interventions. Besides, not all overweight or obese people are eligible for all types of treatment. For instance, pharmacological treatment options are advised in patients with a Body Mass Index (BMI) ≥ 30kg/m2 or a BMI ≥ 27kg/m2 with an obesity-related comorbidity, such as hypertension or diabetes mellitus. Several pharmaceutical agents have been developed for treatment of obesity. These medications generally affect appetite and cause weight loss only when the agent is taken in adjunct to lifestyle modification. Mean weight loss with pharmacological treatment ranges between 4.4 and 14.3%, depending on type of medication and treatment regime.

Bariatric surgery, also called metabolic surgery, includes a variety of surgical procedures in which the gastro-intestinal tract is altered. The most performed types of surgery are the Sleeve Gastrectomy (SG) and the Roux-en-Y gastric bypass (RYGB). All types of surgery cause changes in gut hormones, bile acids and microbiota, which subsequently induce changes in appetite and energy expenditure and thereby causing weight loss. Surgery is generally advised to patients with a BMI ≥ 40kg/m2 or a BMI ≥ 35kg/m2 with comorbid conditions. Compared to lifestyle intervention programs, bariatric surgery has proven to be a superior treatment for morbid obesity. Total weight loss (TWL) is about 20 - 30 %. In addition, bariatric surgery positively influences comorbid conditions, like type 2 diabetes, hypertension, cancer incidence, cardiovascular events and cardiovascular deaths. Thus, currently, bariatric surgery is the most effective treatment for morbid obesity.

However, there is a significant proportion of patients who do not reach "successful" weight loss after bariatric surgery. These patients can be divided in patients who do not reach sufficient weight loss, low responders, and patients who experience weight regain. Although there is no guideline to define who are low responders and what is significant weight regain, unsuccessful weight loss seems to occur in about 20-30% of the population. One of the best predictors of low weight loss in the long-term after surgery is 3-month weight loss. Therefore, this study's clinic provides an extra intervention for the patients who are considered low responders at the 3-month follow-up moment after surgery. The NOK defines a low responder by percentage total weight loss (%TWL) at the 3-month follow-up moment compared to expected weight loss. When %TWL is below the 25% quartile of expected weight loss the patient is considered a low responder. The expected weight loss is determined based on this clinics database of previous patients with the same baseline Body Mass Index (BMI above or below 50 kg/m2), gender and type of surgery. Thus, in the current treatment program patients have a medical consultation in which weight loss is determined three months after surgery. Based on baseline weight and exact number of days after surgery it is calculated whether the patient is a low responder with respect to a private database (currently about 6000 patients). If a patient is considered a low responder then the patient will receive three extra counselling sessions focusing on improving weight loss outcome. This extra intervention is called the plus module and is an addition to the standard program, which consists of multidisciplinary group counselling before and after surgery.

Secondary and/or tertiary bariatric procedures are performed in up to 25% of the patients with unsuccessful weight loss. Although additional surgery can lead to successful weight loss and resolution of comorbid conditions, morbidity and mortality rates of these procedures are higher. Therefore, attention has been focused on pharmacological treatment as an addition to bariatric surgery.

One of the agents that has been suggested for additional pharmacological treatment is semaglutide. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue which was initially developed to treat type 2 diabetes. GLP-1 is one of the incretins, a peptide hormone which is normally secreted from L cells in the distal ileum and colon. When secreted, GLP-1 causes an increase in insulin secretion of the beta-cells of the pancreas and a decrease of glucagon production of the alfa-cells. These changes cause a decrease of fasting and post prandial plasma glucose. In addition, GLP-1 also causes delayed gastric emptying. In non-bariatric patients, semaglutide has shown to improve glycaemic control, decrease blood pressure, lower cardiovascular risk and decrease body weight up to one year.

In this trial the effect of semaglutide 2.4 mg once weekly to the plus module for low responders on the improvement of weight loss compared to patient solely receiving the plus module will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI before surgery was ≥ 35.0 kg/m2
  • Patient is treated with group consultation at the NOK
  • Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)
  • Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.

Exclusion criteria

  • Gastropareses or gastro-intestinal complaints after bariatric surgery
  • Type 1 or type 2 diabetes and/or diabetic retinopathy
  • Decreased renal function (creatinine clearance < 30 ml/min)
  • Liver failure (all)
  • Congestive heart failure or angina pectoris NYHA class III and IV
  • Malignancy in history
  • Pancreatitis (in history)
  • (expected) Pregnancy / breast-feeding
  • Inflammatory Bowel Disease
  • Thyroid malignancy in history
  • Use of warfarin or other coumarin derivates

Treatment and study plan

Placebo

Other

The placebo will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.

Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]

Drug

The semaglutide will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.

Other names: Wegovy, Semaglutide

Primary outcomes

  1. Weight change from start study at 3 months post operative until 15 months later

    Time frame: 15 months

    To study the weight change from 3 until 18 months after surgery (% total weight loss, TWL) in low responders after bariatric surgery who are treated with Semaglutide 2.4 mg and a lifestyle intervention

  2. Difference between placebo group and treatment group in weight change

    Time frame: 15 months

    compare change in weight to patients receiving placebo and a lifestyle intervention

Secondary outcomes

  1. Weight loss 3 months after surgery

    Time frame: 3 months

    To study the weight loss at 3 months after surgery (before semaglutide start)

  2. Weight loss 6 months after surgery

    Time frame: 6 months

    To study the weight loss at 6 months after surgery (3 months after semaglutide start)

  3. Weight loss 12 months after surgery

    Time frame: 12 months

    To study the weight loss at 12 months after surgery (9 months after semaglutide start)

  4. Weight loss 18 months after surgery

    Time frame: 18 months

    To study the weight loss at18 months after surgery (15 months after semaglutide start)

  5. Metabolic health before surgery (bloodpressure)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: bloodpressure in mmHg

  6. Metabolic health before surgery (HbA1c)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: HbA1c in mmol/mol

  7. Metabolic health before surgery (glucose)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: glucose in mmol/l

  8. Metabolic health before surgery (triglyceride)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: triglycerides in mmol/l

  9. Metabolic health before surgery (LDL)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: LDL in mmol/l

  10. Metabolic health before surgery (HDL)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: HDL in mmol/l

  11. Metabolic health before surgery (total cholesterol)

    Time frame: Screening for surgery

    To study metabolic health before surgery (before semaglutide start) by using the following parameter: total cholesterol in mmol/l

  12. Metabolic health 3 months after surgery (Bloodpressure)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: bloodpressure in mmHg

  13. Metabolic health 3 months after surgery (HbA1c)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: HbA1c mmol/mol

  14. Metabolic health 3 months after surgery (glucose)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: glucose in mmol/l

  15. Metabolic health 3 months after surgery (triglyceride)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: triglycerides in mmol/l

  16. Metabolic health 3 months after surgery (LDL)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: LDL in mmol/l

  17. Metabolic health 3 months after surgery (HDL)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: HDL in mmol/l

  18. Metabolic health 3 months after surgery (total cholesterol)

    Time frame: 3 months

    To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: total cholesterol in mmol/l

  19. Metabolic health at 6 months after surgery (bloodpressure)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: bloodpressure in mmHg

  20. Metabolic health at 6 months after surgery (HbA1c)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: HbA1c in mmol/mol

  21. Metabolic health at 6 months after surgery (glucose)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: glucose mmol/l

  22. Metabolic health at 6 months after surgery (triglyceride)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: triglycerides in mmol/l

  23. Metabolic health at 6 months after surgery (LDL)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: LDL in mmol/l

  24. Metabolic health at 6 months after surgery (HDL)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: HDL in mmol/l

  25. Metabolic health at 6 months after surgery (total cholesterol)

    Time frame: 6 months

    To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: total cholesterol in mmol/l

  26. Metabolic health at 12 months after surgery (bloodpressure)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: bloodpressure in mmHg

  27. Metabolic health at 12 months after surgery (HbA1c)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: HbA1c in mmol/mol

  28. Metabolic health at 12 months after surgery (glucose)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: glucose in mmol/l

  29. Metabolic health at 12 months after surgery (triglyceride)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: triglycerides in mmol/l

  30. Metabolic health at 12 months after surgery (LDL)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: LDL in mmol/l

  31. Metabolic health at 12 months after surgery (HDL)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: HDL in mmol/l

  32. Metabolic health at 12 months after surgery (total cholesterol)

    Time frame: 12 months

    To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: total cholesterol in mmol/l

  33. Metabolic health at 18 months after surgery (bloodpressure)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: bloodpressure in mmHg

  34. Metabolic health at 18 months after surgery (HbA1c)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: HbA1c in mmol/mol

  35. Metabolic health at 18 months after surgery (glucose)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: glucose mmol/l

  36. Metabolic health at 18 months after surgery (triglyceride)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: triglycerides in mmol/l

  37. Metabolic health at 18 months after surgery (LDL)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: LDL in mmol/l

  38. Metabolic health at 18 months after surgery (HDL)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: HDL in mmol/l

  39. Metabolic health at 18 months after surgery (total cholesterol)

    Time frame: 18 months

    To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: total cholesterol mmol/l

  40. Health-related quality of life also related to gastro intestinal symptoms before surgery

    Time frame: Screening for surgery

    To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms before surgery (before semaglutide start) using the BODY-Q questionnaire

  41. Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery

    Time frame: 3 months

    To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms at start of treatment (at semaglutide start) questionnaire

  42. Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery

    Time frame: 6 months

    To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 6 months after surgery (3 months after semaglutide start) questionnaire

  43. Health-related quality of life also related to gastro intestinal symptoms

    Time frame: 12 months

    To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 12 months after surgery (9 months after semaglutide start) questionnaire

  44. Health-related quality of life also related to gastro intestinal symptoms

    Time frame: 18 months

    To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 18 months after surgery (15 months after semaglutide start) questionnaire

  45. Cardiorespiratory fitness level before surgery

    Time frame: Screening for surgery

    To evaluate the change in cardiorespiratory fitness level of the participants before surgery (before semaglutide start ) using a VO2 max test

  46. Cardiorespiratory fitness level 3 months after surgery

    Time frame: 3 months

    To evaluate the change in cardiorespiratory fitness level of the participants 3 months after surgery (at semaglutide start) using a VO2 max test

  47. Cardiorespiratory fitness level 6 months after surgery

    Time frame: 6 months

    To evaluate the change in cardiorespiratory fitness level of the participants 6 months after surgery (3 months after semaglutide start) using a VO2 max test

  48. Cardiorespiratory fitness level 12 months after surgery

    Time frame: 12 months

    To evaluate the change in cardiorespiratory fitness level of the participants 12 months after surgery (9 months after semaglutide start) using a VO2 max test

  49. Cardiorespiratory fitness level 18 months after surgery

    Time frame: 18 months

    To evaluate the change in cardiorespiratory fitness level of the participants 18 months after surgery (15 months after semaglutide start) using a VO2 max test

  50. Change in liver fat and liver stiffness at start of treatment

    Time frame: Screening for study

    To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, at start of treatment with semaglutide

  51. Change in liver fat and liver stiffness 15 months after semaglutide start

    Time frame: 15 months

    To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, 15 months after semaglutide start

  52. To describe the persistence of therapy

    Time frame: 15 months

    The number of patients who persisted the therapy given in the study

  53. To describe the average weekly dose

    Time frame: 15 months

    The number of patient on all possible dosages at the end of the study.

Study contacts

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

Marijn Jense, MD

CONTACT

[email protected]

+3188-4599719

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Collaborators

  • Nederlandse Obesitas Kliniek

Registry information

Acronym: SEABAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Mar 1, 2024

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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