Actively Recruiting
Magnetic Compression Anastomosis in Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (MAGvMED Study)
Led by GT Metabolic Solutions, Inc. · Updated on 2026-05-19
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates adults with obesity and type 2 diabetes, comparing two treatments to improve diabetes control. It evaluates the functional improvement of type 2 diabetes by using the Magnet System in a side-to-side duodeno-ileostomy surgery versus semaglutide medication. Participants have a body mass index between 30 and 40 kg/m2 and a hemoglobin A1c level of at least 6.5%. The study is sponsored by GT Metabolic Solutions, Inc. and aims to assess how each treatment affects diabetes over time. Participants are randomly assigned to one of two groups: one group receives the Magnet System device to create a duodeno-ileostomy through magnetic compression anastomosis, and the other group receives semaglutide medication as a weekly subcutaneous injection up to 2.4 mg or a dose tolerated based on side effects. The study prohibits additional metabolic or bariatric surgeries and the use of other GLP-1 receptor agonists during the study period. The treatment phase lasts up to one year with assessments scheduled accordingly. Throughout the study, participants will undergo evaluations including measurement of their hemoglobin A1c levels at day 360 to determine functional improvement in diabetes control. Researchers will monitor adherence to treatment, safety, and any side effects. Participants will provide informed consent and comply with follow-up visits and assessments for the full duration of the study, which extends to June 2028.
CONDITIONS
Brief Title
Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Body Mass Index (BMI) between 30 and 40 kg/m2 and qualifies for obesity treatment as assessed by the investigator
- Diagnosed with type 2 diabetes with HbA1c of 6.5% or higher
- Willing to avoid additional metabolic or bariatric surgery affecting body weight during the study
- Willing to avoid other semaglutide-containing or GLP-1 receptor agonist medications during the study
- Able and willing to comply with study requirements and provide written informed consent
You will not qualify if you...
- Contraindications for either Magnet System surgery or semaglutide medication prohibiting randomization
- Metabolic or bariatric surgery within the past 12 months
- Use of semaglutide or other GLP-1 receptor agonist medications within the past 12 months
- Pregnant, breastfeeding, or planning pregnancy during the study and follow-up
- Participating in other investigational drug, biologic, or device studies
- Medical, social, or psychological conditions limiting participation or compliance with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive the Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition.
Duration - Up to 12 months
Participants receive weekly subcutaneous injections of Semaglutide (up to 2.4mg or dose tolerated) as a glucagon-like peptide-1 receptor agonist.
Trial Site Locations
Total: 1 location
1
Westmount Surgical Center
Westmount, Quebec, Canada, H3Z 2P9
Actively Recruiting
Research Team
L
Lisa Griffin Vincent, PhD, MA
J
Josh Schumacher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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