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

What Was Tested

This registered phase 2, phase 3 trial tested Tirzepatide.

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.

It had two arms (groups): Tirzepatide Group (experimental) and Control - Standard of care Post-Gastric Bypass Surgery (other).

The registry classes the interventions as drug and other.

More on the Plan

Obesity affects nearly half of the U.S. population, impacting health outcomes including diabetes, cardiovascular risk, longevity, and quality of life.

However, nearly two-thirds of patients taking medications like TRZ have mild to moderate gastrointestinal (GI) symptoms, including nausea, vomiting, and abdominal pain.

These medication side-effects could be a consequence of gastroparesis via vagal stimulation of the stomach, and may represent a major driver of weight loss.

Limited data exist regarding use of these newer agents, such as TRZ, in patients who have undergone gastric bypass, which disrupts vagal nerves responsible for managing food transit and gastric emptying.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 25 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subject must be able to understand and provide informed consent. BMI \> 30 12 months after bariatric surgery. Age \> 25 and \< 65. Patients undergoing primary Roux-en-Y Gastric Bypass.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-10-30 with completion listed for 2027-01-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Weight loss (time frame: baseline to 24 weeks). Gastrointestinal symptoms (time frame: baseline to 24 weeks).

It also tracked 3 secondary outcomes, for example Change in body composition, Acetaminophen Area Under the Curve and Lean body mass.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Tirzepatide in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.