Comparing a weight-loss drug and ear nerve stimulation for obesity
Tests a weight-loss drug and ear nerve stimulation in adults with obesity.
Plain-language title generated from the registry record
Registry title: Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study
Key facts
- Where
- Moscow, RussiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 50 years old?
Source: NCT07866183, who can take part
Where in Russia
- National Medical Research Center for Therapy and Preventive MedicineMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Medical Research Center for Therapy and Preventive Medicine
- Trial code
- NCT07866183
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study
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.
Inclusion: Age 25 to 50 years; Low cardiovascular risk according to the SCORE scale (SCORE <1%); Written informed consent to participate in the study.
Exclusion: Cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree; Any acute disease or chronic disease in the stage of exacerbation and/or decompensation; 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.