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GRABS-0
Enrolling by invitationPhase 2, PHASE3GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
30
estimated
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Body weight, absolute change (kg)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Subject must be able to understand and provide informed consent.
2. BMI > 30 12 months after bariatric surgery.
3. Age > 25 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
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
7 endpointsWeight loss
Time frame:baseline to 24 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in body composition
Time frame:baseline to 24 weeks
Total fat mass
change from baseline, improvement
Lean body mass
Time frame:24 weeks
Lean mass
change from baseline, improvement
weight regain after TRZ discontinuation
Time frame:weeks 24 to 48
change from baseline, improvement
Obesity remission
Time frame:baseline to 24 weeks
threshold achievement, improvement
change in anthropometric measurements
Time frame:baseline to 24 weeks
change from baseline, improvement
changes in body composition
Time frame:baseline to 24 weeks.
change from baseline, improvement
Glycemic / diabetes
1 endpointChanges in response to mixed meal tolerance test
Time frame:baseline to 24 weeks
change from baseline, improvement
componentsPostprandial glucose, C-peptide AUC, Plasma concentration (steady state)
Cardiometabolic biomarkers
1 endpointRemission of pre-existing comorbidities
Time frame:baseline to 24 weeks.
composite event, improvement
componentsT2DM prevention, LDL-C, change, Systolic BP, change
Patient-reported / QoL
2 endpointsChange in PAGI-SYM sub-scale scores
Time frame:baseline to 24 weeks
change from baseline, improvement
change in PAGI-SYM scores in the TRZ arm
Time frame:baseline to week 24 and week 24 to week 28 (after TRZ discontinuation)
change from baseline, improvement
Safety / tolerability / PK
5 endpointsGastrointestinal symptoms
Time frame:baseline to 24 weeks
change from baseline, descriptive
Acetaminophen Area Under the Curve
Time frame:baseline to 24 weeks
AUC₀–∞
concentration, descriptive
Difference in acetaminophen AUC between groups
Time frame:baseline to 24 weeks
AUC₀–∞
concentration, descriptive
Medication adherence
Time frame:baseline to 24 weeks
descriptive
Adverse events and healthcare resource utilization
Time frame:baseline to 48 weeks
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), All-cause hospitalization
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.