Side-to-Side Duodeno-ileostomy vs Semaglutide for Obesity and Type 2 Diabetes

(MAGvMED Trial)

Overseen By Lisa Griffin Vincent, PhD, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GT Metabolic Solutions, Inc.

Must not be taking: Semaglutide, GLP-1RA

Disqualifiers: Pregnancy, Recent surgery, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for individuals with obesity and type 2 diabetes. One option involves a surgery called side-to-side duodeno-ileostomy using a special device, while the other uses semaglutide, a medication that manages blood sugar levels. The researchers aim to determine which treatment more effectively manages these conditions. Ideal participants should have a body mass index (BMI) between 30 and 40 and have type 2 diabetes. Participants should not have undergone recent weight-loss surgery or used semaglutide in the past year. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for obesity and type 2 diabetes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that semaglutide is safe for people with obesity, regardless of diabetes status. Research indicates that its safety remains consistent across different doses, with side effects typically predictable and manageable. Common side effects include nausea and mild digestive issues.

Similarly, side-to-side duodeno-ileostomy (a type of surgery) has demonstrated promising safety results. Studies have found that patients effectively lose weight without serious nutritional problems or unusual bodily changes. Overall, both treatments are generally well-tolerated, but individual experiences can vary. Always discuss potential risks with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for obesity and type 2 diabetes because they offer new approaches beyond standard options like lifestyle changes, metformin, or insulin therapy. Semaglutide, a medication arm in the trial, works by mimicking a hormone that increases insulin production and reduces appetite, potentially leading to significant weight loss. On the other hand, the side-to-side duodeno-ileostomy surgery provides a novel method of re-routing the intestines, which may alter digestion and improve metabolic outcomes. These innovative approaches could offer more effective and diverse options for managing these complex conditions.

What evidence suggests that this trial's treatments could be effective for obesity and type 2 diabetes?

This trial will compare the effectiveness of side-to-side duodeno-ileostomy surgery and semaglutide for managing obesity and type 2 diabetes. Research has shown that side-to-side duodeno-ileostomy surgery can help people lose weight and improve type 2 diabetes. In one study, patients lost an average of 34.2 kg and reduced their excess weight by 66.2%, with all patients experiencing improvements in type 2 diabetes. Meanwhile, research indicates that semaglutide aids in weight loss and diabetes management. On average, patients taking semaglutide lost about 15.7 kg more than those not on the medication, with 44.2% losing at least 10% of their body weight over two years. Both treatments, tested in separate arms of this trial, show promise for managing obesity and type 2 diabetes. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

Adults with obesity (BMI between 30 - 40 kg/m2) and Type 2 diabetes (HbA1c ≥ 6.5%) who haven't had weight loss surgery in the past year or taken semaglutide/GLP-1RA medications can join this trial. They must be willing to follow the study plan, avoid additional weight loss surgeries, and not take any excluded medications during the study.

Inclusion Criteria

I understand the study and agree to follow its requirements.

My BMI is between 30 and 40, and I qualify for obesity treatment.

I agree not to have weight-related surgery during the study.

Exclusion Criteria

Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study

Pregnant, lactating or planning pregnancy during the clinical study and follow-up period

I have had weight loss surgery in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Magnet System surgery or semaglutide medication

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide
• Side-to-Side Duodeno-ileostomy

Trial Overview

The trial is comparing a surgical procedure using the Magnet System for side-to-side duodeno-ileostomy against taking semaglutide, a medication for obesity and Type 2 diabetes. Participants will be randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: Surgery Arm Active Control 1 Intervention

Magnet System

Group II: Medication Arm Active Control 1 Intervention

Semaglutide

Who Is Running the Clinical Trial?

GT Metabolic Solutions, Inc.

Lead Sponsor

Trials

8

Recruited

290+

Citations

1.

diabetesjournals.org

diabetesjournals.org/diabetes/article/74/Supplement_1/1733-P/159240/1733-P-Two-Year-Real-World-Effectiveness-of

Two-Year Real-World Effectiveness of Semaglutide in Patients ...

Body weight reductions of ≥5%, ≥10%, ≥15%, and ≥20% from baseline at 2 years were observed in 90.5%, 69.8%, 46.9%, and 29.6% of patients, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12474578/

Semaglutide 2.4 mg Clinical Outcomes in Patients with ...

Compared with patients who did not take obesity medication, patients taking semaglutide 2.4 mg lost 15.7 kg (34.6 pounds) more on average.

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2032183

Once-Weekly Semaglutide in Adults with Overweight or ...

2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight.

4.

nature.com

nature.com/articles/s41591-024-02996-7

Long-term weight loss effects of semaglutide in obesity ...

semaglutide showed a 20% reduction in major adverse cardiovascular events 44.2% achieved 10% weight loss with semaglutide at 2 years, compared ...

5.

ajconline.org

ajconline.org/article/S00029149%2824%2900319-9/fulltext

A Systematic Review and Meta-Analysis of Randomized ...

Our results suggest that semaglutide is beneficial for promoting sustained weight loss in adults with overweight/obesity and without diabetes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11613982/

Effectiveness and safety of semaglutide in overweight/obese ...

Conclusion: Semaglutide can effectively lose weight in overweight or obese adults with or without diabetes, potentially providing cardiovascular ...

7.

diabetesjournals.org

diabetesjournals.org/diabetes/article/74/Supplement_1/1966-LB/158768/1966-LB-Efficacy-and-Safety-of-Semaglutide-7-2-mg

1966-LB: Efficacy and Safety of Semaglutide 7.2 mg in Obesity ...

Conclusion: Sema 7.2 mg was superior to 2.4 mg and pbo for %WL in adults with obesity, with a similar safety profile to sema 2.4 mg. graphic.