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

Severe Obesity Clinical Trial

— GRABS-0  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162715
• Other study ID #: VR72411
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Jason M Samuels, MD
• Phone: (615) 322 4504
• Email: jason.m.samuels[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). We 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 receive a placebo.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: January 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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 insulin, in the previous 90 days.

5. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery.

6. Personal history of pancreatitis as determined by history.

7. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2

8. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.

9. Use of systemic glucocorticoids in the past 28 days

10. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history.

11. History of solid organ transplant.

12. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.

13. Current uncontrolled hypertension (systolic >150, diastolic >90) or untreated hyperthyroidism.

14. 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.

15. Screening creatinine elevation with EGFR < 60 at time of randomization.

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

Drug:
• Tirzepatide
Tirzepatide will be initiated 12 months 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.
• Placebo
Patients randomized to the control group will receive an identical injection of carrier only.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Change in weight over time.	24 weeks
Primary	Gastrointestinal symptoms	Gastroparesis Cardinal Symptom Index	24 weeks
Secondary	Weight change from drug discontinuation	Changes in weight	week 24 - 48.