NCT06162715Active, not recruitingPhase 2/3
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Nov 2023
- Start date
- 30 Oct 2024
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity
- NCT number
- NCT06162715
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 30
- From 30 Oct 2024 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric, vertical banded gastroplasty).
- Use of medications for type 2 di
- Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery.
- 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.
Other illness
- Diagnosis of type I Diabetes
- Personal history of pancreatitis as determined by history.
- Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2
- Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history.
- History of solid organ transplant.
- History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.
- Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism.
Lab values
- Hemoglobin A1c \> 8.5 in last 3 months.
- Screening creatinine elevation with EGFR \< 60 at time of randomization.
Other
- Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
- Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.
- Use of systemic glucocorticoids in the past 28 days
- Tobacco use in last 12 months
- Pregnancy
- Prisoners
- Unable or unwilling to follow-up
- Unable to understand English/Spanish
Who the study is looking for
- Subject must be able to understand and provide informed consent.
- BMI \> 30 12 months after bariatric surgery.
- Age \> 25 and \< 65
- Patients undergoing primary Roux-en-Y Gastric Bypass
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
Related publications
- GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Trial: Rationale, Design and Baseline Characteristics.Diabetes Obes Metab · 2026 · PMID 42712125
This page is information, not medical advice. Discuss any trial with your doctor.