Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Obesity Clinical Trial

— SEABAR  

Official title:

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287307
• Other study ID #: NOK000024
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: Zuyderland Medisch Centrum
• Contact: Marijn Jense, MD
• Phone: +3188-4599719
• Email: m.jense[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: September 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Weight Gain

Intervention

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

Drug:
• Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]
The semaglutide will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Nederlandse Obestias Kliniek (NOK)

References & Publications (23)

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Reges O, Greenland P, Dicker D, Leibowitz M, Hoshen M, Gofer I, Rasmussen-Torvik LJ, Balicer RD. Association of Bariatric Surgery Using Laparoscopic Banding, Roux-en-Y Gastric Bypass, or Laparoscopic Sleeve Gastrectomy vs Usual Care Obesity Management With All-Cause Mortality. JAMA. 2018 Jan 16;319(3):279-290. doi: 10.1001/jama.2017.20513. — View Citation

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Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224. — View Citation

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Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914. — View Citation

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Tettero OM, Monpellier VM, Janssen IMC, Steenhuis IHM, van Stralen MM. Early Postoperative Weight Loss Predicts Weight Loss up to 5 Years After Roux-En-Y Gastric Bypass, Banded Roux-En-Y Gastric Bypass, and Sleeve Gastrectomy. Obes Surg. 2022 Sep;32(9):2891-2902. doi: 10.1007/s11695-022-06166-x. Epub 2022 Jul 16. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change from start study at 3 months post operative until 15 months later	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	15 months
Primary	Difference between placebo group and treatment group in weight change	compare change in weight to patients receiving placebo and a lifestyle intervention	15 months
Secondary	Weight loss 3 months after surgery	To study the weight loss at 3 months after surgery (before semaglutide start)	3 months
Secondary	Weight loss 6 months after surgery	To study the weight loss at 6 months after surgery (3 months after semaglutide start)	6 months
Secondary	Weight loss 12 months after surgery	To study the weight loss at 12 months after surgery (9 months after semaglutide start)	12 months
Secondary	Weight loss 18 months after surgery	To study the weight loss at18 months after surgery (15 months after semaglutide start)	18 months
Secondary	Metabolic health before surgery (bloodpressure)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: bloodpressure in mmHg	Screening for surgery
Secondary	Metabolic health before surgery (HbA1c)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: HbA1c in mmol/mol	Screening for surgery
Secondary	Metabolic health before surgery (glucose)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: glucose in mmol/l	Screening for surgery
Secondary	Metabolic health before surgery (triglyceride)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: triglycerides in mmol/l	Screening for surgery
Secondary	Metabolic health before surgery (LDL)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: LDL in mmol/l	Screening for surgery
Secondary	Metabolic health before surgery (HDL)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: HDL in mmol/l	Screening for surgery
Secondary	Metabolic health before surgery (total cholesterol)	To study metabolic health before surgery (before semaglutide start) by using the following parameter: total cholesterol in mmol/l	Screening for surgery
Secondary	Metabolic health 3 months after surgery (Bloodpressure)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: bloodpressure in mmHg	3 months
Secondary	Metabolic health 3 months after surgery (HbA1c)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: HbA1c mmol/mol	3 months
Secondary	Metabolic health 3 months after surgery (glucose)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: glucose in mmol/l	3 months
Secondary	Metabolic health 3 months after surgery (triglyceride)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: triglycerides in mmol/l	3 months
Secondary	Metabolic health 3 months after surgery (LDL)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: LDL in mmol/l	3 months
Secondary	Metabolic health 3 months after surgery (HDL)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: HDL in mmol/l	3 months
Secondary	Metabolic health 3 months after surgery (total cholesterol)	To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: total cholesterol in mmol/l	3 months
Secondary	Metabolic health at 6 months after surgery (bloodpressure)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: bloodpressure in mmHg	6 months
Secondary	Metabolic health at 6 months after surgery (HbA1c)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: HbA1c in mmol/mol	6 months
Secondary	Metabolic health at 6 months after surgery (glucose)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: glucose mmol/l	6 months
Secondary	Metabolic health at 6 months after surgery (triglyceride)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: triglycerides in mmol/l	6 months
Secondary	Metabolic health at 6 months after surgery (LDL)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: LDL in mmol/l	6 months
Secondary	Metabolic health at 6 months after surgery (HDL)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: HDL in mmol/l	6 months
Secondary	Metabolic health at 6 months after surgery (total cholesterol)	To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: total cholesterol in mmol/l	6 months
Secondary	Metabolic health at 12 months after surgery (bloodpressure)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: bloodpressure in mmHg	12 months
Secondary	Metabolic health at 12 months after surgery (HbA1c)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: HbA1c in mmol/mol	12 months
Secondary	Metabolic health at 12 months after surgery (glucose)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: glucose in mmol/l	12 months
Secondary	Metabolic health at 12 months after surgery (triglyceride)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: triglycerides in mmol/l	12 months
Secondary	Metabolic health at 12 months after surgery (LDL)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: LDL in mmol/l	12 months
Secondary	Metabolic health at 12 months after surgery (HDL)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: HDL in mmol/l	12 months
Secondary	Metabolic health at 12 months after surgery (total cholesterol)	To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: total cholesterol in mmol/l	12 months
Secondary	Metabolic health at 18 months after surgery (bloodpressure)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: bloodpressure in mmHg	18 months
Secondary	Metabolic health at 18 months after surgery (HbA1c)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: HbA1c in mmol/mol	18 months
Secondary	Metabolic health at 18 months after surgery (glucose)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: glucose mmol/l	18 months
Secondary	Metabolic health at 18 months after surgery (triglyceride)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: triglycerides in mmol/l	18 months
Secondary	Metabolic health at 18 months after surgery (LDL)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: LDL in mmol/l	18 months
Secondary	Metabolic health at 18 months after surgery (HDL)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: HDL in mmol/l	18 months
Secondary	Metabolic health at 18 months after surgery (total cholesterol)	To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: total cholesterol mmol/l	18 months
Secondary	Health-related quality of life also related to gastro intestinal symptoms before 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	Screening for surgery
Secondary	Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery	To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms at start of treatment (at semaglutide start) questionnaire	3 months
Secondary	Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery	To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 6 months after surgery (3 months after semaglutide start) questionnaire	6 months
Secondary	Health-related quality of life also related to gastro intestinal symptoms	To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 12 months after surgery (9 months after semaglutide start) questionnaire	12 months
Secondary	Health-related quality of life also related to gastro intestinal symptoms	To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 18 months after surgery (15 months after semaglutide start) questionnaire	18 months
Secondary	Cardiorespiratory fitness level before surgery	To evaluate the change in cardiorespiratory fitness level of the participants before surgery (before semaglutide start ) using a VO2 max test	Screening for surgery
Secondary	Cardiorespiratory fitness level 3 months after surgery	To evaluate the change in cardiorespiratory fitness level of the participants 3 months after surgery (at semaglutide start) using a VO2 max test	3 months
Secondary	Cardiorespiratory fitness level 6 months after surgery	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	6 months
Secondary	Cardiorespiratory fitness level 12 months after surgery	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	12 months
Secondary	Cardiorespiratory fitness level 18 months after surgery	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	18 months
Secondary	Change in liver fat and liver stiffness at start of treatment	To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, at start of treatment with semaglutide	Screening for study
Secondary	Change in liver fat and liver stiffness 15 months after semaglutide start	To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, 15 months after semaglutide start	15 months
Secondary	To describe the persistence of therapy	The number of patients who persisted the therapy given in the study	15 months
Secondary	To describe the average weekly dose	The number of patient on all possible dosages at the end of the study.	15 months