Recruiting

Magnet System with Semaglutide

Sponsor:

GT Metabolic Solutions, Inc.

Code:

NCT07317115

Conditions

Obesity (Disorder)

Obesity & Overweight

Type 2 Diabetes (T2DM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnet System

Semaglutide

Study Details

Brief summary:

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

Conditions

Obesity (Disorder)

Obesity & Overweight

Type 2 Diabetes (T2DM)

Study ID

NCT07317115

Start date

Mar 18, 2026

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Surgery Arm

Magnet System

active comparator: Medication Arm

Semaglutide

Interventions

Magnet System

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

Semaglutide

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Westmount Surgical Center

Recruiting

Westmount, Quebec, Canada, H3Z 2P9

Contacts

Principal Investigator:

Michel Gagner, MD

More Information

Sponsor

GT Metabolic Solutions, Inc.

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Magnet System
  • Semaglutide
  • GT Metabolic Solutions, Inc.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GT Metabolic Solutions, Inc. on 2026-05-19.