GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Feasibility Trial (GRABS-0)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Obesity
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jason M Samuels, MD; Phone Number: 24504 (615) 322 4504; Email: jason.m.samuels@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tirzepatide Group; Patients will receive Tirzepatide beginning 12 months after undergoing Roux-en-Y Gastric Bypass following an adaptive modified dose titration protocol to a maximum dose of 15 mg weekly.	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.; Other Names: Mounjaro; Zepbound
Placebo Comparator: Control; Patients in this group will receive a placebo but will follow the same protocol as patients in the Tirzepatide group.	Drug: Placebo; Patients randomized to the control group will receive an identical injection of carrier only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Change in weight over time.	24 weeks
Gastrointestinal symptoms	Gastroparesis Cardinal Symptom Index	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change from drug discontinuation	Changes in weight	week 24 - 48.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Jason M Samuels, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: bariatric surgery; Roux-en-Y Gastric Bypass; Tirzepatide; GLP-1 Receptor Agonists
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: VR72411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No