NCT07866183Recruiting
Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Oct 2026
- Start date
- 29 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Diseases
- Obesity
- NCT number
- NCT07866183
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 29 Jun 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- Age 25 to 50 years.
- Low cardiovascular risk according to the SCORE scale (SCORE \<1%).
- Written informed consent to participate in the study
Age in the registry: 25 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Research Center for Therapy and Preventive Medicine Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.