RecruitingNot ApplicableNCT07317115

Side-to-Side Duodeno-ileostomy Versus Semaglutide in 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)

Sponsor

GT Metabolic Solutions, Inc.

Enrollment

20 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.

Interventions

DEVICEMagnet System

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

DRUGSemaglutide

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)