ObesityNCT06073457
Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")
A study testing MagGJ System in people with Obesity and Type 2 Diabetes, run by GT Metabolic Solutions, Inc. at 4 sites in 4 countries.
Trial summary
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- MagGJ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 6 Nov 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age, inclusive, at the time of informed consent
- BMI 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (>12 months) and indicated for a gastro-ileal diversion; OR
- BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A) Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB), with the second stage gastric pouch stapling performed >12 months after the gastro-ileal diversion, and not part of the investigational study
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
- If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
- Willing and able to comply with protocol requirements
Who cannot join
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled T2DM
- Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/or cholecystectomy with the investigational study gastro-ileal anastomosis procedure
- Uncontrolled hypertension, dyslipidemia or sleep apnea
- Prior intestinal, colonic or duodenal surgery, other than bariatric
Show all 34Show fewer
- Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
- Refractory gastro-esophageal reflux disease (GERD)
- Barrett's disease
- Helicobacter pylori positive and/or active ulcer disease
- Large hiatal hernia
- Inflammatory bowel or colonic diverticulitis disease
- Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
- Implantable pacemaker or defibrillator
- Psychiatric disorder, except well-controlled depression with medication for > 6 months
- History of substance abuse
- Woman who is either pregnant or breast feeding
- Woman of childbearing potential who does not agree to use an effective method of contraception.
- Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets.
- Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnet deployment site
- Expected MR imaging within a two-month window following the study procedure
- Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures
- Underwent a surgery/intervention within the 30 days proceeding the study procedure
- Any scheduled surgical or interventional procedure planned within 30 days post-study procedure
- Any stroke/TIA within 6 months prior to informed consent
- Requires chronic anticoagulation therapy (except aspirin)
- Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
- Unable to comply with the follow-up schedule and assessments
- Recent tobacco or nicotine product cessation; cessation ≤ 3 months prior to informed consent
- Known allergies to the device components or contrast media
- Limited life expectancy due to terminal disease
- Currently participating in another clinical research study with an investigational drug or medical device
- A positive COVID-19 test prior to the study procedure, where indicated by local COVID-19 protocols for procedure/surgical clearance
- Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, GJ Biofragmentable to Achieve Gastro-Ileal or Gastro-Jejunal Diversion in Adults With Obesity
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults.
Read the detailed description
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum is intended to facilitate weight management/loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus ("T2DM"). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single anastomosis sleeve ileal (SASI) bypass procedure that includes a gastro-ileostomy at the distal antrum of the stomach. Additionally, the one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) performed in two stages may also be considered a predicate procedure where an anastomosis between the jejunum and anterior lesser curvature of the stomach is performed, followed by a second stage gastric pouch stapling more than 12 months later (non-study procedure).
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- MagGJ System
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagGJ SystemDevice
Anastomoses achieved by magnetic compression.
| Study group | Role | What they receive |
|---|---|---|
| MagGJ System | Experimental | GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") Receives: Device: MagGJ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnet Placement
MagGJ System placement ≥ 90% alignment of magnets
Measured: 1 Day
Natural Magnet Passage
Passage of magnets without surgical re-intervention
Measured: 30 Days
Anastomosis Patency
Confirmed radiologically or fluoroscopically
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start6 Nov 2023
- Primary completion17 Apr 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A 2-stage, open-label, multicenter study enrolling up to 35 subjects at 6 study centers, as follows: * Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 subjects; and * Stage 2: Feasibility with up to 30 subjects There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GT Metabolic Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073457
- Sponsor's protocol ID
- GTM-003
- Status last verified
- May 2026
- First submitted
- 17 Jul 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, GJ Biofragmentable to Achieve Gastro-Ileal or Gastro-Jejunal Diversion in Adults With Obesity
- ClinicalTrials.gov ID
- NCT06073457
- Acronym / sponsor ID
- GTM-003
- Conditions
- Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults.
Detailed description
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum is intended to facilitate weight management/loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus ("T2DM"). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single anastomosis sleeve ileal (SASI) bypass procedure that includes a gastro-ileostomy at the distal antrum of the stomach. Additionally, the one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) performed in two stages may also be considered a predicate procedure where an anastomosis between the jejunum and anterior lesser curvature of the stomach is performed, followed by a second stage gastric pouch stapling more than 12 months later (non-study procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 2-stage, open-label, multicenter study enrolling up to 35 subjects at 6 study centers, as follows: * Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 subjects; and * Stage 2: Feasibility with up to 30 subjects There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.
| Arm | Type | Receives |
|---|---|---|
| MagGJ System | Experimental | Device: MagGJ SystemGT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years of age, inclusive, at the time of informed consent
- BMI 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (>12 months) and indicated for a gastro-ileal diversion; OR
- BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A) Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB), with the second stage gastric pouch stapling performed >12 months after the gastro-ileal diversion, and not part of the investigational study
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
- If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
Key exclusion criteria (34 listed)
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled T2DM
- Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/or cholecystectomy with the investigational study gastro-ileal anastomosis procedure
- Uncontrolled hypertension, dyslipidemia or sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagGJ SystemAnastomoses achieved by magnetic compression. | Device | MagGJ System |
Primary outcome
Magnet Placement
Time frame: 1 Day
MagGJ System placement ≥ 90% alignment of magnets
Natural Magnet Passage
Time frame: 30 Days
Passage of magnets without surgical re-intervention
Anastomosis Patency
Time frame: Day 30
Confirmed radiologically or fluoroscopically
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagGJ System in people with Obesity and Type 2 Diabetes, run by GT Metabolic Solutions, Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Chile, Portugal, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnet Placement (time frame: 1 Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.