Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study

What Was Tested

In this not phased trial, researchers set out to test Tirzepatide for fat loss, obesity & body recomposition.

The study focuses on changes in body weight, anthropometric indices, epicardial and visceral adipose tissue, body composition, behavioral factors, skeletal muscle characteristics, and cardiac structure and function.

The study will include 120 participants.

It had three arms (groups): Tirzepatide (Tirzetta) (experimental), HEALBE NEEM transcutaneous auricular vagus nerve stimulation device (experimental) and Control Cohort (no intervention).

The control cohort will include 60 participants: 30 individuals with normal body weight and 30 individuals with class I obesity. Participants in this cohort will not receive tirzepatide or HEALBE NEEM stimulation and will undergo study assessments according to the protocol.

The registry classes the interventions as device and drug.

More on the Plan

The study evaluates adults with normal body weight or class I obesity and low cardiovascular risk.

Behavioral risk factors will be characterized, including conventional and electronic cigarette smoking, alcohol consumption, anxiety and depressive symptoms, sleep disturbances, and eating behavior.

Transthoracic echocardiography will be used to assess routine structural and functional parameters together with epicardial adipose tissue thickness, E/e', tricuspid regurgitation velocity, TAPSE, interventricular septal thickness, left ventricular posterior wall thickness, and left ventricular end-diastolic dimension.

Associations among anthropometric, behavioral, clinical-anamnestic, laboratory, and instrumental parameters will be analyzed.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 25 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 25 to 50 years. Written informed consent to participate in the study.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree; expected technical difficulties with use of the stimulation device by the participant; any acute disease or chronic disease in the stage of exacerbation and/or decompensation.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2026-06-29 with completion listed for 2027-06.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Eating behavior - AEBQ, Sleep quality - PSQI, Perceived stress - PSS-10, Anxiety and depression - HADS, Alcohol use - AUDIT and Cigarette consumption.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tirzepatide in 120 people with fat loss, obesity & body recomposition.

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.