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Not yet recruitingNCT06287307SEABARUpdated Mar 1, 2024

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

A Phase 4 interventional study of Placebo and Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] in Obesity, Obesity, Morbid and Weight Gain, sponsored by Zuyderland Medisch Centrum. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-01.

Primary conditionObesity, MorbidRegistry: ObesityReclassifiedWhy we changed it
Registry
Obesity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity, Morbid
Why
  1. The study's listed conditions name Obesity, Morbid, a narrower term within Obesity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Zuyderland Medisch Centrum · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Obesity
  • Obesity, Morbid
  • Weight Gain

Browse trials for

Keywords

  • Obesity
  • Semaglutide
  • GLP-1
  • Bariatric Surgery
  • Weight Loss
03

In context

Obesity, Morbid Reclassified

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 152 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.

Compared within Obesity, Morbid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria:

  • Gastropareses or gastro-intestinal complaints after bariatric surgery
  • Type 1 or type 2 diabetes and/or diabetic retinopathy
  • Decreased renal function ( \< 30 ml/min)
  • Liver failure (all)
  • Congestive heart failure or angina pectoris class III and IV
  • in history
  • Pancreatitis (in history)
  • (expected) Pregnancy / breast-feeding
  • Inflammatory Bowel Disease
  • Thyroid malignancy in history
  • Use of warfarin or other coumarin derivates
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
152 participants (estimated)

Study arms

  • Active comparator
    Semaglutide 2.4mg

    Patients in this group will receive the active comparator semaglutide 2.4mg. This is a medication which is distributed by an intramuscular injection once weekly.

    Drug: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]

  • Placebo comparator
    Placebo

    Patients in this group will receive the placebo. This is a placebo which is distributed by an intramuscular injection once weekly.

    Other: Placebo

Interventions

  • OtherPlacebo

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

  • DrugSemaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]

    Drug page: Semaglutide

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

    Also known as: Wegovy, Semaglutide

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 15 months

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

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

    Time frame: 15 months

Secondary outcomes

  1. Weight loss 3 months after surgery

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

    Time frame: 3 months

  2. Weight loss 6 months after surgery

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

    Time frame: 6 months

  3. Weight loss 12 months after surgery

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

    Time frame: 12 months

  4. Weight loss 18 months after surgery

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

    Time frame: 18 months

  5. Metabolic health before surgery (bloodpressure)

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

    Time frame: Screening for surgery

  6. Metabolic health before surgery (HbA1c)

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

    Time frame: Screening for surgery

  7. Metabolic health before surgery (glucose)

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

    Time frame: Screening for surgery

  8. Metabolic health before surgery (triglyceride)

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

    Time frame: Screening for surgery

  9. Metabolic health before surgery (LDL)

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

    Time frame: Screening for surgery

  10. Metabolic health before surgery (HDL)

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

    Time frame: Screening for surgery

  11. 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

    Time frame: Screening for surgery

  12. 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

    Time frame: 3 months

  13. 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

    Time frame: 3 months

  14. 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

    Time frame: 3 months

  15. 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

    Time frame: 3 months

  16. 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

    Time frame: 3 months

  17. 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

    Time frame: 3 months

  18. 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

    Time frame: 3 months

  19. 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

    Time frame: 6 months

  20. 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

    Time frame: 6 months

  21. 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

    Time frame: 6 months

  22. 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

    Time frame: 6 months

  23. 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

    Time frame: 6 months

  24. 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

    Time frame: 6 months

  25. 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

    Time frame: 6 months

  26. 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

    Time frame: 12 months

  27. 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

    Time frame: 12 months

  28. 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

    Time frame: 12 months

  29. 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

    Time frame: 12 months

  30. 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

    Time frame: 12 months

  31. 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

    Time frame: 12 months

  32. 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

    Time frame: 12 months

  33. 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

    Time frame: 18 months

  34. 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

    Time frame: 18 months

  35. 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

    Time frame: 18 months

  36. 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

    Time frame: 18 months

  37. 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

    Time frame: 18 months

  38. 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

    Time frame: 18 months

  39. 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

    Time frame: 18 months

  40. 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

    Time frame: Screening for surgery

  41. 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

    Time frame: 3 months

  42. 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

    Time frame: 6 months

  43. 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

    Time frame: 12 months

  44. 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

    Time frame: 18 months

  45. 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

    Time frame: Screening for surgery

  46. 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

    Time frame: 3 months

  47. 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

    Time frame: 6 months

  48. 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

    Time frame: 12 months

  49. 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

    Time frame: 18 months

  50. 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

    Time frame: Screening for study

  51. 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

    Time frame: 15 months

  52. To describe the persistence of therapy

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

    Time frame: 15 months

  53. To describe the average weekly dose

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

    Time frame: 15 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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  • Busetto L, Dicker D, Azran C, Batterham RL, Farpour-Lambert N, Fried M, Hjelmesaeth J, Kinzl J, Leitner DR, Makaronidis JM, Schindler K, Toplak H, Yumuk V. Practical Recommendations of the Obesity Management Task Force of the European Association for the Study of Obesity for the Post-Bariatric Surgery Medical Management. Obes Facts. 2017;10(6):597-632. doi: 10.1159/000481825. Epub 2017 Dec 6. PubMed 29207379 ↗
  • Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10.1210/jc.2014-3415. Epub 2015 Jan 15. Erratum In: J Clin Endocrinol Metab. 2015 May;100(5):2135-6. doi: 10.1210/jc.2015-1782. PubMed 25590212 ↗
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  • Sjostrom L. Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013 Mar;273(3):219-34. doi: 10.1111/joim.12012. Epub 2013 Feb 8. PubMed 23163728 ↗
  • Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934. PubMed 24149519 ↗
  • 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. PubMed 29340677 ↗
  • 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. PubMed 22215166 ↗
  • Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003641. doi: 10.1002/14651858.CD003641.pub3. PubMed 19370590 ↗
  • Karmali S, Brar B, Shi X, Sharma AM, de Gara C, Birch DW. Weight recidivism post-bariatric surgery: a systematic review. Obes Surg. 2013 Nov;23(11):1922-33. doi: 10.1007/s11695-013-1070-4. PubMed 23996349 ↗
  • 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. PubMed 35842505 ↗
  • Mor A, Sharp L, Portenier D, Sudan R, Torquati A. Weight loss at first postoperative visit predicts long-term outcome of Roux-en-Y gastric bypass using Duke weight loss surgery chart. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):556-60. doi: 10.1016/j.soard.2012.06.014. Epub 2012 Jul 16. PubMed 22920966 ↗
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  • RJ Rosenthal. Failure of weight loss or weight regain after bariatric surgery. Bariatric Times. 2012.
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  • Brethauer SA, Kothari S, Sudan R, Williams B, English WJ, Brengman M, Kurian M, Hutter M, Stegemann L, Kallies K, Nguyen NT, Ponce J, Morton JM. Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):952-72. doi: 10.1016/j.soard.2014.02.014. Epub 2014 Feb 22. PubMed 24776071 ↗
  • Christou GA, Katsiki N, Blundell J, Fruhbeck G, Kiortsis DN. Semaglutide as a promising antiobesity drug. Obes Rev. 2019 Jun;20(6):805-815. doi: 10.1111/obr.12839. Epub 2019 Feb 15. PubMed 30768766 ↗
  • Shaefer CF Jr, Kushner P, Aguilar R. User's guide to mechanism of action and clinical use of GLP-1 receptor agonists. Postgrad Med. 2015;127(8):818-26. doi: 10.1080/00325481.2015.1090295. Epub 2015 Sep 15. PubMed 26371721 ↗
  • Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831. PubMed 33625476 ↗
  • Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. PubMed 33567185 ↗
  • 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. PubMed 33755728 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06287307
Lead sponsor
Zuyderland Medisch Centrum
Collaborators
Nederlandse Obestias Kliniek (NOK)
Responsible party
Sponsor
First posted
Mar 1, 2024
Start date
May 2024 (estimated)
Primary completion
Feb 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Mar 1, 2024

Study contacts

Marijn Jense, MD
Contact
m.jense@zuyderland.nl
+3188-4599719
Jan Willem Greve, prof
principal investigator · Zuyderland Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Semaglutide

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Zuyderland Medisch Centrum

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