SEABAR

Not yet recruitingPhase 4

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Lead sponsor

Zuyderland Medisch Centrum

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

152

Study population

Bariatric Surgery, Obesity / overweight

Eligibility highlights

•BMI ≥35

Primary endpoints

•Body weight, % change•Body weight, absolute change (kg)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06287307

Org study IDNOK000024

Timeline

Milestones

Study first posted2024-03-01actual

Last update posted2024-03-01actual

Study start2024-05estimated (month precision)

Primary completion2026-02estimated (month precision)

Study completion2026-09estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Bariatric SurgeryObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (55)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

MASH / liver

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

6 endpoints

Primary/protocol endpoint

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

Time frame:15 months

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Difference between placebo group and treatment group in weight change

Time frame:15 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Weight loss 3 months after surgery

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

Weight loss 6 months after surgery

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Weight loss 12 months after surgery

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Weight loss 18 months after surgery

Time frame:18 months

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Secondary/protocol endpoint

Metabolic health before surgery (HbA1c)

Time frame:Screening for surgery

descriptive

LOINC 4548-4

Secondary/protocol endpoint

Metabolic health before surgery (glucose)

Time frame:Screening for surgery

descriptive

Secondary/protocol endpoint

Metabolic health 3 months after surgery (HbA1c)

Time frame:3 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Metabolic health 3 months after surgery (glucose)

Time frame:3 months

descriptive

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (HbA1c)

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (glucose)

Time frame:6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (HbA1c)

Time frame:12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (glucose)

Time frame:12 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (HbA1c)

Time frame:18 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (glucose)

Time frame:18 months

descriptive, improvement

MASH / liver

2 endpoints

Secondary/protocol endpoint

Change in liver fat and liver stiffness at start of treatment

Time frame:Screening for study

change from baseline, improvement

componentsLiver fat content, change, Liver stiffness (VCTE), change

Secondary/protocol endpoint

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

Time frame:15 months

change from baseline, improvement

componentsLiver fat content, change, Liver stiffness (VCTE), change

Cardiometabolic biomarkers

25 endpoints

Secondary/protocol endpoint

Metabolic health before surgery (bloodpressure)

Time frame:Screening for surgery

descriptive

Secondary/protocol endpoint

Metabolic health before surgery (triglyceride)

Time frame:Screening for surgery

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Metabolic health before surgery (LDL)

Time frame:Screening for surgery

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Metabolic health before surgery (HDL)

Time frame:Screening for surgery

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Metabolic health before surgery (total cholesterol)

Time frame:Screening for surgery

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Metabolic health 3 months after surgery (Bloodpressure)

Time frame:3 months

descriptive, improvement

Secondary/protocol endpoint

Metabolic health 3 months after surgery (triglyceride)

Time frame:3 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Metabolic health 3 months after surgery (LDL)

Time frame:3 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Metabolic health 3 months after surgery (HDL)

Time frame:3 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Metabolic health 3 months after surgery (total cholesterol)

Time frame:3 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (bloodpressure)

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (triglyceride)

Time frame:6 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (LDL)

Time frame:6 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (HDL)

Time frame:6 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Metabolic health at 6 months after surgery (total cholesterol)

Time frame:6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (bloodpressure)

Time frame:12 months

descriptive, improvement

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (triglyceride)

Time frame:12 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (LDL)

Time frame:12 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (HDL)

Time frame:12 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Metabolic health at 12 months after surgery (total cholesterol)

Time frame:12 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (bloodpressure)

Time frame:18 months

descriptive, improvement

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (triglyceride)

Time frame:18 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (LDL)

Time frame:18 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (HDL)

Time frame:18 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Metabolic health at 18 months after surgery (total cholesterol)

Time frame:18 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

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

Time frame:Screening for surgery

descriptive

Secondary/protocol endpoint

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

Time frame:3 months

descriptive, improvement

Secondary/protocol endpoint

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

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

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

Time frame:12 months

descriptive, improvement

Secondary/protocol endpoint

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

Time frame:18 months

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

To describe the average weekly dose

Time frame:15 months

descriptive

Other clinical outcomes

5 endpoints

Secondary/protocol endpoint/low confidence

Cardiorespiratory fitness level before surgery

Time frame:Screening for surgery

descriptive

Secondary/protocol endpoint

Cardiorespiratory fitness level 3 months after surgery

Time frame:3 months

descriptive

Secondary/protocol endpoint

Cardiorespiratory fitness level 6 months after surgery

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Cardiorespiratory fitness level 12 months after surgery

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Cardiorespiratory fitness level 18 months after surgery

Time frame:18 months

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

To describe the persistence of therapy

Time frame:15 months

descriptive

Publications (22)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
Obesity surgery2022 Sep (month)PMID35842505doi:10.1007/s11695-022-06166-xvia CT.gov background
Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.
JAMA2021 Apr 13PMID33755728doi:10.1001/jama.2021.3224via CT.gov background
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.
JAMA2021 Apr 13PMID33625476doi:10.1001/jama.2021.1831via CT.gov background
Once-Weekly Semaglutide in Adults with Overweight or Obesity.
The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov background
Semaglutide as a promising antiobesity drug.
Obesity reviews : an official journal of the International Association for the Study of Obesity2019 Jun (month)PMID30768766doi:10.1111/obr.12839via CT.gov background
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.
JAMA2018 Jan 16PMID29340677doi:10.1001/jama.2017.20513via CT.gov background
Reoperative Bariatric Surgery: a Systematic Review of the Reasons for Surgery, Medical and Weight Loss Outcomes, Relevant Behavioral Factors.
Obesity surgery2017 Oct (month)PMID28791623doi:10.1007/s11695-017-2855-7via CT.gov background
Practical Recommendations of the Obesity Management Task Force of the European Association for the Study of Obesity for the Post-Bariatric Surgery Medical Management.
Obesity facts2017 (year)PMID29207379doi:10.1159/000481825via CT.gov background
Management of obesity.
Lancet (London, England)2016 May 7PMID26868660doi:10.1016/S0140-6736(16)00271-3via CT.gov background
A Comparison of New Pharmacological Agents for the Treatment of Obesity.
The Annals of pharmacotherapy2016 May (month)PMID26887340doi:10.1177/1060028016634351via CT.gov background
Pharmacological management of obesity: an endocrine Society clinical practice guideline.
The Journal of clinical endocrinology and metabolism2015 Feb (month)PMID25590212doi:10.1210/jc.2014-3415via CT.gov background
User's guide to mechanism of action and clinical use of GLP-1 receptor agonists.
Postgraduate medicine2015 (year)PMID26371721doi:10.1080/00325481.2015.1090295via CT.gov background
European Guidelines for Obesity Management in Adults.
Obesity facts2015 (year)PMID26641646doi:10.1159/000442721via CT.gov background
Mechanisms of changes in glucose metabolism and bodyweight after bariatric surgery.
The lancet. Diabetes & endocrinology2014 Feb (month)PMID24622719doi:10.1016/S2213-8587(13)70218-3via CT.gov background
Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force.
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery2014 Sep-Oct (year)PMID24776071doi:10.1016/j.soard.2014.02.014via CT.gov background
Revisional bariatric surgery is more effective for improving obesity-related co-morbidities than it is for reinducing major weight loss.
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery2014 Jul-Aug (year)PMID24708909doi:10.1016/j.soard.2013.12.007via CT.gov background
Weight recidivism post-bariatric surgery: a systematic review.
Obesity surgery2013 Nov (month)PMID23996349doi:10.1007/s11695-013-1070-4via CT.gov background
Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials.
BMJ (Clinical research ed.)2013 Oct 22PMID24149519doi:10.1136/bmj.f5934via CT.gov background
Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery.
Journal of internal medicine2013 Mar (month)PMID23163728doi:10.1111/joim.12012via CT.gov background
Bariatric surgery and long-term cardiovascular events.
JAMA2012 Jan 4PMID22215166doi:10.1001/jama.2011.1914via CT.gov background
Weight loss at first postoperative visit predicts long-term outcome of Roux-en-Y gastric bypass using Duke weight loss surgery chart.
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery2012 Sep-Oct (year)PMID22920966doi:10.1016/j.soard.2012.06.014via CT.gov background
Surgery for obesity.
The Cochrane database of systematic reviews2009 Apr 15PMID19370590doi:10.1002/14651858.CD003641.pub3via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.