An interventional study of Tirzepatide and Transcutaneous auricular vagus nerve stimulation in Class I Obesity, sponsored by National Medical Research Center for Therapy and Preventive Medicine. Recruiting at 1 site in Russia. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by National Medical Research Center for Therapy and Preventive Medicine · Not applicable, Interventional, and Treatment
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.
The study evaluates adults with normal body weight or class I obesity and low cardiovascular risk. The principal objective is to compare the effectiveness of pharmacological therapy with tirzepatide and a non-pharmacological approach based on transcutaneous auricular vagus nerve stimulation for weight reduction in participants with class I obesity, while also including a non-intervention control cohort for comparative assessment.
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.
At the first visit, complaints and medical history will be collected, a physical examination will be performed, and blood pressure, body mass index, waist circumference, waist-to-hip ratio, and waist-to-height ratio will be assessed. Fasting blood will be collected for a complete blood count and biochemical testing, including glucose and uric acid, to screen for somatic pathology and chronic non-communicable diseases. Cardiovascular risk will be assessed using the SCORE scale.
Instrumental examinations will include transthoracic echocardiography, bioelectrical impedance analysis, comprehensive ultrasound assessment of adipose tissue distribution and skeletal muscle structure, and assessment of muscle strength.
The study will comprise three groups. Group 1 will include 30 participants with class I obesity receiving Tirzetta (tirzepatide) according to the approved prescribing information. Group 2 will include 30 participants with class I obesity using the HEALBE NEEM transcutaneous auricular vagus nerve stimulation device. The device stimulates the auricular branch of the vagus nerve. In the appetite-reduction program, stimulation is delivered at a frequency of 20 Hz. Each session lasts 10 minutes and is performed approximately 30 minutes before meals. Group 3 will be a non-intervention control cohort of 60 participants: 30 individuals with normal body weight and 30 individuals with class I obesity.
Follow-up visits will take place at Weeks 8, 16, and 24. Anthropometric measurements and instrumental examinations will be repeated and study endpoints will be recorded.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's planned enrollment of 120 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →National Medical Research Center for Therapy and Preventive Medicine is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants will receive Tirzetta according to the approved prescribing information. The source protocol does not specify a dose-escalation schedule.
Drug: Tirzepatide
The HEALBE NEEM device will be used for non-invasive transcutaneous stimulation of the auricular branch of the vagus nerve. In the appetite-reduction program, stimulation is delivered at 20 Hz. Each session lasts 10 minutes and is performed approximately 30 minutes before meals.
Device: Transcutaneous auricular vagus nerve stimulation
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.
Tirzepatide is administered to participants with Class I obesity according to the approved prescribing information throughtout the 24-week study
Transcutaneous 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.
Time frame: Baseline, Week 8, Week 16, and Week 24.
Percentage reduction in waist-to-height ratio
Percentage change in waist-to-height ratio from baseline
Time frame: Baseline, Week 8, Week 16, and Week 24
Percentage reduction in epicardial adipose tissue thickness
Percentage change in echocardiographically measured epicardial adipose tissue thickness from baseline
Time frame: Baseline and Week 24.
Percentage reduction in visceral adipose tissue
Percentage change in visceral adipose tissue from baseline, assessed according to the study imaging protocol
Time frame: Baseline and Week 24
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)
Time frame: Baseline and Week 24
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)
Time frame: Baseline and Week 24
Perceived stress - PSS-10
Change in total score on the 10-item Perceived Stress Scale (PSS-10)
Time frame: Baseline and Week 24
Anxiety and depression - HADS
Changes in Anxiety and Depression subscale scores within the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and Week 24
Alcohol use - AUDIT
Change in Alcohol Use Disorders Identification Test (AUDIT) score
Time frame: Baseline and Week 24
Cigarette consumption
Change in the number of cigarettes smoked per day
Time frame: Baseline and Week 24
Left atrial reservoir strain
Percentage increase in left atrial reservoir strain
Time frame: Baseline and Week 24
Left ventricular reservoir strain
Percentage increase in left ventricular reservoir strain, as specified in the source protocol
Time frame: Baseline and Week 24
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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National Medical Research Center for Therapy and Preventive Medicine