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

NCT ID: NCT07317115

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-06-30

Brief Summary

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

Detailed Description

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Compare functional improvement of T2D using the Magnet System in duodeno-ileostomy for intestinal diversion versus semaglutide in eligible participants with obesity (BMI 30 - 40 kg/m2) and T2D (HbA1c ≥ 6.5%).

Conditions

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Obesity (Disorder) Obesity & Overweight Type 2 Diabetes (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

1:1 randomization of Surgery (MagDI System) versus Medication (semaglutide). At Day 360, subjects in the Medication arm will have the option to crossover to the Surgery Arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery Arm

Magnet System

Group Type ACTIVE_COMPARATOR

Magnet System

Intervention Type DEVICE

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

Medication Arm

Semaglutide

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type 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)

Interventions

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Magnet System

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

Intervention Type DEVICE

Semaglutide

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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Participant has been informed of the nature of the study and is willing and able to comply with requirements, including randomization, and provides written informed consent to participate in the study.

Exclusion Criteria

* 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.
* Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study.
* Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, would contraindicate either treatment arm or could limit the participant's ability to participate in the clinical study or to comply with follow-up requirements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GT Metabolic Solutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Westmount Surgical Center

Westmount, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lisa Griffin Vincent, PhD, MA

Role: CONTACT

+1 763-200-1416

Josh Schumacher

Role: CONTACT

+1 763-200-1416

Facility Contacts

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Gismonde Gnanhoue

Role: primary

(514)-922-5055

Other Identifiers

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GTM-021

Identifier Type: -

Identifier Source: org_study_id

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