Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists

What Was Tested

This registered not phased trial tested Tirzepatide for fat loss, obesity & body recomposition.

This is a single-center, randomized, participant-blinded, sham-controlled trial designed to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight or obese patients who show a suboptimal weight-loss response to incretin receptor agonist therapy.

The primary objective is to compare the percent change in body weight from baseline to week 12 between the two groups.

It had two arms (groups): one (experimental) and one (sham comparator).

The registry classes the interventions as device.

More on the Plan

Before and after intervention, all participants will undergo standardized assessments, including lifestyle questionnaires, anthropometric measurements, body composition analysis, autonomic function evaluation, laboratory testing, and assessment of hepatic steatosis and fibrosis.

Autonomic function assessment will include heart rate variability, cardiovascular autonomic reflex tests, sudomotor function, and brain MRI.

Liver-related assessments will include FibroTouch and liver MRI.

During follow-up, body weight will be monitored weekly by telephone or WeChat, waist circumference, hip circumference, and body composition will be reassessed every 4 weeks, and device use will be monitored through an app to ensure adherence and protocol consistency.

Who Took Part

24 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Willingness to provide written informed consent.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: skin infection or damage involving the auricular area;; women planning pregnancy in the near future;; contraindications to mri, such as metallic prostheses or claustrophobia;.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

In this single-blind Tirzepatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2026-08-01 with completion listed for 2027-06-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Body Weight From Baseline (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks).

It also tracked 15 secondary outcomes, for example Change in Waist Circumference, Change in Body Composition and Fat Distribution, Change in blood glucose, Change in Hip Circumference, Change in Visceral Fat Area and Change in Glycated Hemoglobin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tirzepatide in 24 people with fat loss, obesity & body recomposition.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Fat loss, obesity & body recomposition research.