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

NCT06162715 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: VR72411
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Severe Obesity; Obesity; BMI Greater Than 30

Keywords

bariatric surgery; Roux-en-Y Gastric Bypass; GLP-1 Receptor Agonists; Tirzepatide; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Change in weight over time.

  baseline to 24 weeks

Secondary Outcomes (4)

• Change in body composition

  baseline to 24 weeks

• Gastrointestinal symptoms

  baseline to 24 weeks

• Acetaminophen Area Under the Curve

  baseline to 24 weeks

• Lean body mass

  24 weeks

Other Outcomes (11)

• weight regain after TRZ discontinuation

  weeks 24 to 48

• Obesity remission

  baseline to 24 weeks

• Remission of pre-existing comorbidities

  baseline to 24 weeks.

Study Arms (2)

Tirzepatide Group

EXPERIMENTAL

Participants in the TRZ cohort will initiate a standardized dose titration as described in the package insert. Participants will begin TRZ at 2.5 mg for four weeks and then increase by 2.5 mg every 4 weeks to a maximum dose of 15 mg. If subjects experience intolerable GI symptoms, they will be allowed to decrease to a lower dose by 2.5 mg for 2 weeks, at which point another attempt at an increased dose will be trialed. Should patients not tolerate a higher dose a second time, they will have the dose again lowered by 2.5 mg and kept at the lower dose for the remainder of the study, except for patients who do not tolerate two attempts at 5 mg. For patients who fail to titrate to at least 5 mg TRZ, a third attempt at an increased dose will be attempted 4 weeks after the second decrease in dose. These patients will then remain on 5 mg for the remainder of the intervention period. All participants receiving TRZ will be pooled in terms of outcomes measures.

Drug: Tirzepatide

Control - Standard of care Post-Gastric Bypass Surgery

OTHER

Patients randomized to the control arm will receive the standard of care for weight maintenance after gastric bypass including dietary guidance provided by the Vanderbilt Surgical Weight Loss handbook for 24 weeks. After 24 weeks, particiapnts in the control arm will crossover to the Tirzepatide arm and receive 24 weeks of TRZ following the same titration.

Other: Standard of Care post-gastric bypass

Interventions

Tirzepatide DRUG

Tirzepatide will be initiated 12 or 18 months (12 months + 24 weeks) 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.

Also known as: Zepbound, Mounjaro

Tirzepatide Group

Standard of Care post-gastric bypass OTHER

Patients randomized to the control arm will receive the standard of care for weight maintenance after gastric bypass including dietary guidance provided by the Vanderbilt Surgical Weight Loss handbook. This includes recommendations for 64 oz of fluids per day, ≥60 grams of protein/day, and daily bariatric multivitamins. Patients will continue to have access to dedicated bariatric dietitians, advanced practice providers, and surgeons on an ad hoc basis per patients' request.

Control - Standard of care Post-Gastric Bypass Surgery

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to understand and provide informed consent.
• BMI \> 30 12 months after bariatric surgery.
• Age \> 30 and \< 65
• Patients undergoing primary Roux-en-Y Gastric Bypass

You may not qualify if:

• Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
• Diagnosis of type I Diabetes
• Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric, vertical banded gastroplasty).
• Use of medications for type 2 di
• Hemoglobin A1c \> 8.5 in last 3 months.
• Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery.
• 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
• Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.
• Use of systemic glucocorticoids in the past 28 days
• 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.
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Jason M Samuels, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: October 30, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Per institutional policy, data will be maintained in the local REDCap data repository for 6 years after closure of the study. Following this period, data will be deidentified and uploaded to the OSF repository, which has funding for at least 50 years of data storage.

Locations

US (1)