Side-to-side duodeno-ileostomy with magnets versus semaglutide for adults with obesity and type 2 diabetes
Magnetic Compression Anastomosis in Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (MAGvMED Study)
This trial tests whether a magnet-assisted side-to-side duodeno-ileostomy surgery or the medication semaglutide works better to improve blood sugar control and weight in adults with obesity and type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GT Metabolic Solutions, Inc. Industry-sponsored |
| Locations | 1 site (Westmount, Quebec) |
| Trial ID | NCT07317115 on ClinicalTrials.gov |
What this trial studies
Eligible adults with BMI 30–40 kg/m2 and type 2 diabetes (HbA1c ≥ 6.5%) are randomized to receive either a magnet system to create a side-to-side duodeno-ileostomy (an intestinal diversion procedure) or treatment with the GLP-1 receptor agonist semaglutide. The study compares functional improvements in diabetes and weight-related outcomes between the surgical device approach and medication over follow-up. Participants must agree to avoid additional metabolic or bariatric surgery and not take other semaglutide-containing or GLP-1RA medications for the study duration. The trial is sponsored by GT Metabolic Solutions, Inc. and conducted at Westmount Surgical Center in Westmount, Quebec.
Who should consider this trial
Good fit: Adults with obesity (BMI 30–40 kg/m2) and type 2 diabetes (HbA1c ≥ 6.5%) who are medically eligible for either the device procedure or semaglutide and are willing to be randomized and follow study restrictions are the intended candidates.
Not a fit: People with BMI outside the 30–40 range, contraindications to either the magnet system or semaglutide, or those unwilling/unable to avoid other GLP-1RA drugs or additional bariatric surgery are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the magnet-assisted duodeno-ileostomy could offer an alternative way to improve diabetes and promote weight loss comparable to semaglutide.
How similar studies have performed: Semaglutide and conventional bariatric surgeries have demonstrated benefits for weight loss and glycemic control, while magnet-created intestinal diversion is a more novel device approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Westmount, Quebec
- Westmount Surgical Center — Westmount, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Lisa Griffin Vincent, PhD, MA
- Email: clinical@gtmetabolic.com
- Phone: +1 763-200-1416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.