Semaglutide 2.4mg for Low Responders After Bariatric Surgery

NCT06287307 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NOK000024
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity; Obesity, Morbid; Weight Gain

Keywords

Obesity; Semaglutide; GLP-1; Bariatric Surgery; Weight Loss

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (53)

• Weight loss 3 months after surgery

  3 months

• Weight loss 6 months after surgery

  6 months

• Weight loss 12 months after surgery

  12 months

• Weight loss 18 months after surgery

  18 months

• Metabolic health before surgery (bloodpressure)

  Screening for surgery

Study Arms (2)

Semaglutide 2.4mg

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Placebo

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.

Also known as: Wegovy, Semaglutide

Semaglutide 2.4mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Nederlandse Obestias Kliniek (NOK): collaborator

Related Publications (23)

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  PMID: 23996349 BACKGROUND

• 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.

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  BACKGROUND

• McKenna D, Selzer D, Burchett M, Choi J, Mattar SG. Revisional bariatric surgery is more effective for improving obesity-related co-morbidities than it is for reinducing major weight loss. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):654-9. doi: 10.1016/j.soard.2013.12.007. Epub 2013 Dec 18.

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  PMID: 24776071 BACKGROUND

• 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.

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• 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.

  PMID: 33625476 BACKGROUND

• 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.

  PMID: 33567185 BACKGROUND

• 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.

  PMID: 33755728 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Weight Gain; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jan Willem Greve, prof

  Zuyderland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marijn Jense, MD

CONTACT

+3188-4599719; m.jense@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: March 1, 2024
• Study Start: May 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share