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Life sciences · Interventional Study
ClinicalTrials.gov · October 8, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07866183). This is a study registration, not published results. Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Class I Obesity. Interventions: DRUG: Tirzepatide; DEVICE: Transcutaneous auricular vagus nerve stimulation. Primary outcome measures: Percentage reduction in body weight , Baseline, Week 8, Week 16, and Week 24.; Percentage reduction in waist-to-height ratio , Baseline, Week 8, Week 16, and Week 24; Percentage reduction in epicardial adipose tissue thickness , Baseline and Week 24.; Percentage reduction in visceral adipose tissue , Baseline and Week 24. Brief summary: 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.