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Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes

ConditionsObesity (Disorder)Obesity & OverweightType 2 Diabetes (T2DM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGT Metabolic Solutions, Inc.

About this trial

Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body Mass Index (BMI) between 30 - 40 kg/m2 and qualifies for obesity treatment at the discretion of the treating investigator (i.e., must be assessed to qualify for both surgery and medication treatment to justify randomization).

Type 2 diabetes (T2D defined as HbA1c ≥ 6.5%).

Participant agrees to refrain from additional metabolic and bariatric (MBS) or reconstructive surgery that would affect body weight for the duration of the study.

Participant agrees to refrain from taking any additional semaglutide-containing or other GLP-1RA medication for the duration of the study, regardless of randomization assignment (i.e., Surgery or Medication).

Disqualifiers

Meets any of the contraindications for either treatment arm (Surgery: Magnet System; or Medication: semaglutide), thereby prohibiting randomization

Current or previous metabolic and bariatric surgery (MBS) treatment in the previous 12 months (e.g., sleeve gastrectomy, intragastric balloons, adjustable gastric banding).

Taking or treated with semaglutide, semaglutide-containing medications, or any other GLP-1RA medication in the previous 12 months.

Pregnant, lactating or planning pregnancy during the clinical study and follow-up period.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Magnet System

    Device

    Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition

  • Semaglutide

    Drug

    Semaglutide (up to 2.4mg subcutaneous (SQ) injection weekly or dose tolerated according to side effects); a glucagon-like peptide-1 receptor agonist (GLP-1RA)

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Surgery ArmActive comparator 1 intervention
Group B: Medication ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional improvement of T2D: HbA1c

Time frame
Day 360

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GT Metabolic Solutions, Inc.

Lead sponsor

Source ClinicalTrials.gov
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