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

GT Metabolic Solutions

Status: Enrolling

Conditions: Type 2 Diabetes (T2DM); Obesity & Overweight; Obesity (Disorder)

Treatments: Device: Magnet System; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07317115

GTM-021

Details and patient eligibility

About

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

Full 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%).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Surgery Arm

Active Comparator group

Description:

Magnet System

Treatment:

Device: Magnet System

Medication Arm

Active Comparator group

Description:

Semaglutide

Treatment:

Drug: Semaglutide