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Trial · Interventional

Status unknownPhase 4Registry data

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Short name SEABAR

NCTNCT06287307 (opens ClinicalTrials.gov in a new tab)Other idNOK000024
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
152 participants (estimated)
Sponsor
Zuyderland Medisch Centrum · Other
Design
Randomized · Double masking
Countries
Not stated
Start
May 2024 (estimated)
Primary completion
Feb 2026 (estimated)
Completion
Sept 2026 (estimated)
First posted
1 Mar 2024
Last update posted
1 Mar 2024
Conditions
Obesity · Obesity, Morbid · Weight Gain

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 4

    SEABAR

    NCT06287307

    est. May 2024 to est. Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms2

  • 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.

  • Placebo comparator

    Placebo

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

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · 15 months

    Registry description

    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

    Registry description

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

Secondary outcomes(20)

  1. Weight loss 3 months after surgery

    Time frame · 3 months

    Registry description

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

  2. Weight loss 6 months after surgery

    Time frame · 6 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2021

6 results

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.

Wadden et al. 2021JAMAcited by 858

PMID 33625476PMC7905697DOI 10.1001/jama.2021.1831PUB-33625476

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2021

6 results

Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.

Rubino et al. 2021JAMAcited by 1,095

PMID 33755728PMC7988425DOI 10.1001/jama.2021.3224PUB-33755728

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Observational study · 2016

A Comparison of New Pharmacological Agents for the Treatment of Obesity.

Nuffer et al. 2016The Annals of pharmacotherapycited by 13

PMID 26887340DOI 10.1177/1060028016634351PUB-26887340

Full text at the publisher
Publisher page

More studies

3 studies on this page

Indexing hint: Review · 2019

Semaglutide as a promising antiobesity drug.

Christou et al. 2019Obesity reviews : an official journal of the International Association for the Study of Obesitycited by 122

PMID 30768766DOI 10.1111/obr.12839PUB-30768766

Full text at the publisher
Publisher page

Indexing hint: Review · 2016

Management of obesity.

Bray et al. 2016Lancet (London, England)cited by 686

PMID 26868660DOI 10.1016/s0140-6736(16)00271-3PUB-26868660

Full text at the publisher
Publisher page

Indexing hint: Review · 2015

User's guide to mechanism of action and clinical use of GLP-1 receptor agonists.

Jr et al. 2015Postgraduate medicinecited by 94

PMID 26371721DOI 10.1080/00325481.2015.1090295PUB-26371721

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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