30 Participants Needed

Tirzepatide for Obesity After Bariatric Surgery

(GRABS-0 Trial)

JM
Overseen ByJason M Samuels, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using medications for type 2 diabetes or systemic glucocorticoids, you may not be eligible to participate.

Is tirzepatide safe for humans?

Tirzepatide has been shown to be generally safe in humans, with common side effects including nausea, vomiting, diarrhea, and constipation, especially at higher doses. It has also been associated with a reduction in certain cardiovascular events, indicating a favorable safety profile in this regard.12345

How does the drug tirzepatide differ from other treatments for obesity after bariatric surgery?

Tirzepatide is unique because it is a dual agonist, targeting both GIP and GLP-1 receptors, which helps in reducing body weight and improving insulin sensitivity more effectively than other treatments. This dual action is not commonly found in other obesity treatments, making it a novel option for weight management after bariatric surgery.46789

What data supports the effectiveness of the drug Tirzepatide for obesity after bariatric surgery?

Tirzepatide has been shown to significantly reduce body weight in patients with type 2 diabetes and obesity, with some losing more than 10% of their initial weight. This suggests it could be effective for weight loss in patients who have had bariatric surgery.145910

Who Is on the Research Team?

JM

Jason M Samuels, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 30-65 with severe obesity (BMI > 50) who have had Roux-en-Y Gastric Bypass surgery. Participants must understand the study and consent to join. Exclusions include type I Diabetes, recent use of certain diabetes medications or tobacco products, history of pancreatitis or some cancers, uncontrolled hypertension, and significant heart issues.

Inclusion Criteria

My BMI was over 50 when I had bariatric surgery.
I am between 31 and 64 years old.
I understand the study and can give my consent.
See 1 more

Exclusion Criteria

Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
I have not taken any steroids in the last 28 days.
Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tirzepatide with dose titration over 24 weeks or standard of care post-gastric bypass

24 weeks
Regular visits for dose titration and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and weight regain after treatment

24 weeks
Periodic visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide
Trial Overview The GRABS trial is testing Tirzepatide's effectiveness in patients post-bariatric surgery compared to those who only undergo the surgery. It aims to see if this drug can help further with weight loss and maintain health after the procedure.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Tirzepatide GroupExperimental Treatment1 Intervention
Group II: Control - Standard of care Post-Gastric Bypass SurgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Published Research Related to This Trial

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.
The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.
Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction.Nauck, MA., D'Alessio, DA.[2022]
In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.
Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.
Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis.Tan, B., Pan, XH., Chew, HSJ., et al.[2023]
Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.
While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.
Weight loss efficiency and safety of tirzepatide: A Systematic review.Lin, F., Yu, B., Ling, B., et al.[2023]

Citations

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]
Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]
Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]
Tirzepatide: Clinical review of the "twincretin" injectable. [2023]
Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]
Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]
A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? [2023]
New Drug: Tirzepatide (Mounjaro™). [2023]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. [2023]
Tirzepatide: First Approval. [2022]
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