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

Study acronym: GRABS-0
StatusActive, Not Recruiting
PhasePhase 2/3
Started2024-10-30
View on ClinicalTrials.gov ↗

Amendment history

2026-08-03
Study Status v15
Trial status changed: Enrolling by Invitation → Active, Not Recruiting
2026-06-01
Study Status, Outcome Measures v14
Primary endpoint(s) modified1 to 2 entries
WasWeight loss
NowGastrointestinal symptoms, Weight loss
Secondary endpoints4 to 3 entries
Gastrointestinal symptoms
2026-05-14
Study Status, Outcome Measures, Eligibility v13
Primary completion moved earlier: 2027-05 → 2027-01-01
Completion date2027-12→2027-12-01
Eligibility criteriarevised
[...] consent. BMI > 30 12 months after bariatric surgery. Age > 3025 and < 65 Patients undergoing primary Roux-en-Y Gastric Bypa [...]
Secondary endpointsdetails revised at 2 of 4 entries
2026-03-05
Study Status, Eligibility v12
Re-verified, no change to tracked fields
2026-02-18
Study Status v11
Primary completion date2027-01→2027-05
Show 10 earlier versions
2025-11-30
Study Status, Study Description, Arms and Interventions v10
Study description+127 characters
[...] to either 24 weeks of TRZ or post-surgery standard of care. Subjects randomized to the standard of care arm will crossover to receive the intervention drug after 24 weeks of observation. Our proposal consists of two aims. First, the investigators [...]
2025-03-07
2 amendments v8-v9
2 re-verifications since 2025-03-04, no change to tracked fields
2024-10-30
Study Status v7
Start dateestimated 2024-11-01→confirmed 2024-10-30
2024-10-24
Study Status, IPDSharing v6
Start date2024-10-01→2024-11-01
2024-10-03
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Enrolling by Invitation
2024-09-24
Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures v4
PhasePhase 2→Phase 2/3
Secondary endpoints3 to 4 entries
Lean body mass
Study title-6 characters
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) FeasibilityPilot Trial
2024-08-30
Study Status, Conditions v3
Re-verified, no change to tracked fields
2024-06-11
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v2
PhasePhase 2/3→Phase 2
Primary completion date2025-08→2027-01
Completion date2026-01→2027-12
Start date2024-05→2024-10-01
Enrollment target45→30
InterventionsPlacebo (Drug), Tirzepatide (Drug)→Standard of Care post-gastric bypass (Other), Tirzepatide (Drug)
Eligibility criteria+151 characters
[...] band, sleeve gastric, vertical banded gastroplasty). Use of insulin,medications for type 2 di Hemoglobin A1c > 8.5 in thelast previous3 90 daysmonths. Patient-reported Tobacco, e-cigarette, or smoked marijuana [...] reatinine elevation with EGFR < 60 at time of randomization. Tobacco use in last 12 months Pregnancy Prisoners Unable or unwilling to follow-up Unable to understand English/Spanish
Secondary endpoints1 to 3 entries
WeightChange changein frombody drugcomposition Gastrointestinal discontinuationsymptoms Acetaminophen Area Under the Curve
Primary endpoints2 to 1 entries
Gastrointestinal symptoms
Study description+2,162 characters
Obesity affects nearly half of the U.S. population, impacting health outcomes including diabetes, cardiovascular risk, longevity, and quality of life. While bariatric surgery such as gastric bypass stands as the most effective intervention, 65% of individuals experience persistent obesity when under [...]
2024-03-07
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
InterventionsTirzepatide (Drug)→Placebo (Drug), Tirzepatide (Drug)
Eligibility criteria-195 characters
Inclusion Criteria: Subject must be able to understand and provide informed consent. BMI > 5030 at12 timemonths ofafter bariatric surgery. Age > 30 and < 65 Patients undergoing primary Roux-en-Y Gas [...] band, sleeve gastric, vertical banded gastroplasty). Use of antidiabetic agentinsulin, other than metformin, including GLP-1R agonist in the previous 90 days. Metformin is allowed provided the dose has been stable in the 90 days prior to screening and will remain stable for the duration of the trial. Patient-reported Tobacco, e-cigarette, or smoked marijuana u [...]
Secondary endpoints+39 characters
Weight change from drug discontinuation
2023-11-30
Original filing
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.
Trial Details
NCT Number NCT06162715
Lead Sponsor Vanderbilt University Medical Center
Conditions Severe Obesity, Obesity, BMI Greater Than 30
Enrollment 30 participants
Start Date 2024-10-30
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-04