GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial

Plain English Summary

GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial is a Phase 3 clinical trial sponsored by Vanderbilt University Medical Center studying Severe Obesity, Obesity, BMI Greater Than 30. This study tests if the drug Tirzepatide can help people maintain weight loss after bariatric surgery. It is for adults aged 30-64 who had Roux-en-Y gastric bypass surgery and have regained weight. Participants will receive either Tirzepatide or standard post-surgery care and diet advice. The alternative is continuing with standard weight management advice after surgery. The trial aims to enroll 30 participants.

Official Summary

The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI \> 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who continue with the current standard of care for patients who have previously undergone Gastric Bypass Surgery.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 30 and 64 years old and have a BMI over 30, 12 months after Roux-en-Y gastric bypass. You cannot join if you have type 1 diabetes, had other types of weight loss surgery, or have certain heart conditions. You also cannot join if you have a history of pancreatitis, certain thyroid cancers, or are pregnant or breastfeeding. This trial is studying Severe Obesity, Obesity, BMI Greater Than 30, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see how much weight participants lose or maintain over 24 weeks, helping to understand if Tirzepatide is effective for weight management post-surgery. The specific primary outcome measures are: Weight loss (baseline to 24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses the challenge of weight regain after bariatric surgery, a common issue for which new treatments are needed. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Severe Obesity, Obesity, BMI Greater Than 30, where improved treatment options are needed.

Investor Insight

This pilot study explores a new use for Tirzepatide in a specific post-bariatric surgery population, potentially expanding its market if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if Tirzepatide is right for you and what the potential benefits and risks are. Participation involves regular visits for drug administration, check-ups, and monitoring of weight and side effects. You will need to follow specific dietary guidelines and take daily vitamins as part of the standard care. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 30 participants

Interventions

• DRUG: Tirzepatide — Tirzepatide will be initiated 12 or 18 months (12 months + 24 weeks) after patients undergo Roux-en-Y Gastric Bypass. Patients will be started on the lowest dose of 2.5 mg and the dose increased every 6 weeks following an adaptive maximum dose titration protocol. Patients will then complete a final 4 weeks of the study drug.
• OTHER: Standard of Care post-gastric bypass — Patients randomized to the control arm will receive the standard of care for weight maintenance after gastric bypass including dietary guidance provided by the Vanderbilt Surgical Weight Loss handbook. This includes recommendations for 64 oz of fluids per day, ≥60 grams of protein/day, and daily bariatric multivitamins. Patients will continue to have access to dedicated bariatric dietitians, advanced practice providers, and surgeons on an ad hoc basis per patients' request.

Primary Outcomes

• Weight loss (baseline to 24 weeks)

Secondary Outcomes

• Change in body composition (baseline to 24 weeks)
• Gastrointestinal symptoms (baseline to 24 weeks)
• Acetaminophen Area Under the Curve (baseline to 24 weeks)
• Lean body mass (24 weeks)

Full Eligibility Criteria

Inclusion Criteria:

1. Subject must be able to understand and provide informed consent.
2. BMI \> 30 12 months after bariatric surgery.
3. Age \> 30 and \< 65
4. Patients undergoing primary Roux-en-Y Gastric Bypass

Exclusion Criteria:

1. Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
2. Diagnosis of type I Diabetes
3. Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric, vertical banded gastroplasty).
4. Use of medications for type 2 di
5. Hemoglobin A1c \> 8.5 in last 3 months.
6. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery.
7. Personal history of pancreatitis as determined by history.
8. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2
9. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.
10. Use of systemic glucocorticoids in the past 28 days
11. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history.
12. History of solid organ transplant.
13. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.
14. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism.
15. Current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
16. Screening creatinine elevation with EGFR \< 60 at time of randomization.
17. Tobacco use in last 12 months
18. Pregnancy
19. Prisoners
20. Unable or unwilling to follow-up
21. Unable to understand English/Spanish

Trial Locations

• Vanderbilt University Medical Center, Nashville, Tennessee, United States

Frequently Asked Questions

Related Conditions

• Obesity
• Severe Obesity
• Morbid Obesity
• Weight Regain
• Bariatric Surgery
• Roux-en-Y Gastric Bypass
• Type 2 Diabetes (as a related condition often managed with weight loss)
• Metabolic Syndrome
• Cardiovascular Disease (risk reduction through weight loss)
• Non-alcoholic Fatty Liver Disease (NAFLD)

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