Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Sponsor
Zuyderland Medisch Centrum
Study ID
NCT06287307
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2024
Status verified
Feb 2024
Primary completion
Feb 28, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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 Outcome Measure

Weight change from start study at 3 months post operative until 15 months later [ Time Frame: 15 months ]

Central Contacts

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