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Clinical Trial NCT07317115 (MAGvMED) for Obesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (MAGvMED) 20
Clinical Trial NCT07317115 (MAGvMED) is an interventional study for Obesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM) that is recruiting. It started on March 1, 2026 with plans to enroll 20 participants. Led by GT Metabolic Solutions, Inc., it is expected to complete by June 1, 2028. The latest data from ClinicalTrials.gov was last updated on February 20, 2026.
Brief Summary
Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
Detailed Description
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%).
Official Title
Magnetic Compression Anastomosis in Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (MAGvMED Study)
Conditions
Obesity (Disorder)Obesity & OverweightType 2 Diabetes (T2DM)Other Study IDs
- MAGvMED
- GTM-021
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-02-20
Completion Date (Estimated)
2028-06
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Magnet System
Semaglutide
GT Metabolic Solutions, Inc.
Semaglutide
GT Metabolic Solutions, Inc.
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorSurgery Arm Magnet System | Magnet System Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition |
Active ComparatorMedication Arm Semaglutide | 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) |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Functional improvement of T2D: HbA1c | Day 360 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
GT Metabolic Solutions, Inc.Study Central Contact
Contact: Lisa Griffin Vincent, PhD, MA, +1 763-200-1416, [email protected]
Contact: Josh Schumacher, +1 763-200-1416, [email protected]
1 Study Locations in 1 Countries
Quebec
Westmount Surgical Center, Westmount, Quebec, H3Z 2P9, Canada
Gismonde Gnanhoue, Contact, (514)-922-5055, [email protected]
Michel Gagner, MD, Principal Investigator
Recruiting