Weight-loss strategies in adults with class I obesity: tirzepatide vs. ear-stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized study compares two active weight-loss approaches in adults with class I obesity and low cardiovascular risk: a pharmacologic treatment with tirzepatide and a non-pharmacologic approach using transcutaneous auricular vagus nerve stimulation. A total of 120 participants (60 in the active-treatment arm split between tirzepatide and vagus stimulation, and 60 in a control cohort including normal-weight and class I obesity individuals) will be followed to assess changes in weight, body composition, and adipose tissue, as well as behavioral factors and cardiac structure and function. Assessments include echocardiography, anthropometrics, lab tests, and questionnaires at baseline and follow-up visits. The study aims to determine relative effectiveness on weight loss and related physiological parameters while exploring associations among lifestyle, clinical, and imaging measures. Eligibility requires ages 25–50, low cardiovascular risk, and informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 25 to 50 years.
* Low cardiovascular risk according to the SCORE scale (SCORE \<1%).
* Written informed consent to participate in the study

Exclusion Criteria:

* 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.

Where it's running

• National Medical Research Center for Therapy and Preventive Medicine
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Oxana Drapkina, MD, DSc, Professor — National Medical Research Center for Therapy and Preventive Medicine
• Study coordinator: Elizaveta Rogozhkina, MD, PhD
• Email: lizarogozkina@gmail.com
• Phone: +7 (937) 104-73-31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Virtual Housecalls for teens: helping adolescents with obesity in primary care

  A telehealth-based program tests a 6-month intensive lifestyle approach to help adolescents aged 12-15 with class I obesity lose weight, using caregiver support and in-person visits plus virtual coaching.

  Recruiting Virginia Commonwealth University · Henrico, Virginia · NCT07246603

• Weight loss and brain health in adults with obesity

  This study tests whether weight loss with semaglutide affects brain health in adults aged 35-55, by comparing people with obesity to lean controls over about 80 weeks.

  Recruiting Phase 4 McGill University · Montreal, Quebec · NCT07592546

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.