Obesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM)
Conditions
Keywords
Magnet System, Semaglutide, GT Metabolic Solutions, Inc.
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%).
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)
Sponsors
GT Metabolic Solutions, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization of Surgery (MagDI System) versus Medication (semaglutide). At Day 360, subjects in the Medication arm will have the option to crossover to the Surgery Arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional improvement of T2D: HbA1c | Day 360 |
Countries
Canada
Contacts
CONTACTLisa Griffin Vincent, PhD, MA
CONTACTJosh Schumacher
Outcome results
None listed