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

Sponsor
GT Metabolic Solutions, Inc.
Study ID
NCT07317115
Status
Recruiting
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Conditions

  • Obesity & Overweight
  • Obesity (Disorder)
  • Type 2 Diabetes (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnet System — DEVICE
    Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition
  • Semaglutide — DRUG
    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)

Study Details

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

Key Dates

Start date
Mar 18, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgery Arm
    Magnet System
  • Active Comparator: Medication Arm
    Semaglutide

Primary Outcome Measure

Functional improvement of T2D: HbA1c [ Time Frame: Day 360 ]

Central Contacts

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