This single-center randomized comparative study is designed to compare the effectiveness of tirzepatide and transcutaneous low-frequency auricular vagus nerve stimulation in adults with class I obesity and without chronic non-communicable diseases. 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. The active-treatment cohort will comprise 60 adults aged 25 to 50 years with class I obesity and low cardiovascular risk. These participants will be assigned to two active-treatment groups: 30 participants will receive tirzepatide (Tirzetta), and 30 participants will receive transcutaneous auricular vagus nerve stimulation using the HEALBE NEEM device. A control cohort of 60 participants will include 30 individuals with normal body weight and 30 individuals with class I obesity who will not receive either study intervention. Follow-up assessments will be conducted at Weeks 8, 16, and 24.
The primary efficacy outcomes are percentage reductions in body weight, waist-to-height ratio, epicardial adipose tissue thickness, and visceral adipose tissue. Secondary outcomes include changes in eating behavior, sleep, perceived stress, anxiety and depression, alcohol consumption, cigarette consumption, and myocardial deformation parameters.
Age 25 to 50 years.
Low cardiovascular risk according to the SCORE scale (SCORE <1%).
Written informed consent to participate in the study
Cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree.
For participants in the obesity cohorts: body mass index greater than or equal to 35 kg/m². Participants with normal body weight may be enrolled in the designated normal-weight control subgroup.
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.
Parallel
Tirzepatide
DrugTirzepatide is administered to participants with Class I obesity according to the approved prescribing information throughtout the 24-week study
Transcutaneous auricular vagus nerve stimulation
DeviceTranscutaneous auricular vagus nerve stimulation (taVNS) is delivered using the HEALBE NEEM device (LARTECH LLC, Saint Petersburg, Russia Federation). Stimulation is applied for 10 minutes approximately 30 minutes before food intake using the appetite-reduction program at frequency 20 Hz
Percentage reduction in body weight
Percentage change in body weight from baseline.
Percentage reduction in waist-to-height ratio
Percentage change in waist-to-height ratio from baseline
Percentage reduction in epicardial adipose tissue thickness
Percentage change in echocardiographically measured epicardial adipose tissue thickness from baseline
Percentage reduction in visceral adipose tissue
Percentage change in visceral adipose tissue from baseline, assessed according to the study imaging protocol
Eating behavior - AEBQ
Changes in Hunger, Food Responsiveness, Emotional Over-Eating, Satiety Responsiveness, and Enjoyment of Food scale scores within the Adult Eating Behaviour Questionnaire (AEBQ)
Sleep quality - PSQI
Changes in Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction component scores within the Pittsburgh Sleep Quality Index (PSQI)
Perceived stress - PSS-10
Change in total score on the 10-item Perceived Stress Scale (PSS-10)
Anxiety and depression - HADS
Changes in Anxiety and Depression subscale scores within the Hospital Anxiety and Depression Scale (HADS)
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