Class I ObesityTIFFANYNCT07866183
Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study
A study testing Tirzepatide and Transcutaneous auricular vagus nerve stimulation in people with Class I Obesity, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Class I Obesity
- What is being tested?
- Tirzepatide and Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jun 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25 to 50 years.
- Low cardiovascular risk according to the SCORE scale (SCORE <1%).
- Written informed consent to participate in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center for Therapy and Preventive Medicine
Moscow
Oksana Drapkina, MD, DSc, +7 (495) 212-07-13, drapkina@bk.ru
Pavel Iarovoi, MD
About this 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.
Read the detailed description
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.
- Conditions
- Class I Obesity
- Being tested
- Tirzepatide, Transcutaneous auricular vagus nerve stimulation
- Keywords
- tirzepatide; Tirzetta; class I obesity; transcutaneous auricular vagus nerve stimulation; weight loss; epicardial adipose tissue; visceral adipose tissue
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzepatide is administered to participants with Class I obesity according to the approved prescribing information throughtout the 24-week study
Transcutaneous auricular vagus nerve stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide (Tirzetta) | Experimental | Participants will receive Tirzetta according to the approved prescribing information. The source protocol does not specify a dose-escalation schedule. Receives: Drug: Tirzepatide |
| HEALBE NEEM transcutaneous auricular vagus nerve stimulation device | Experimental | 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. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
| Control Cohort | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in body weight
Percentage change in body weight from baseline.
Measured: Baseline, Week 8, Week 16, and Week 24.
Percentage reduction in waist-to-height ratio
Percentage change in waist-to-height ratio from baseline
Measured: 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
Measured: 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
Measured: Baseline and Week 24
Secondary outcomes (8)
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)
Measured: 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)
Measured: Baseline and Week 24
Perceived stress - PSS-10
Change in total score on the 10-item Perceived Stress Scale (PSS-10)
Measured: Baseline and Week 24
Anxiety and depression - HADS
Changes in Anxiety and Depression subscale scores within the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline and Week 24
Alcohol use - AUDIT
Change in Alcohol Use Disorders Identification Test (AUDIT) score
Measured: Baseline and Week 24
Cigarette consumption
Change in the number of cigarettes smoked per day
Measured: Baseline and Week 24
Left atrial reservoir strain
Percentage increase in left atrial reservoir strain
Measured: Baseline and Week 24
Left ventricular reservoir strain
Percentage increase in left ventricular reservoir strain, as specified in the source protocol
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start29 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include three groups: 30 participants with class I obesity receiving tirzepatide, 30 participants with class I obesity receiving transcutaneous auricular vagus nerve stimulation using HEALBE NEEM, and a 60-participant non-intervention control cohort consisting of 30 participants with normal body weight and 30 participants with class I obesity.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olga Dzhioeva, MD, PhD, Professor, Study chair, National Medical Research Center for Therapy and Preventive MedicineOxana Drapkina, MD, DSc, Professor, Principal investigator, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866183
- Sponsor's protocol ID
- 04-05/26
- Acronym
- TIFFANY
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study
- ClinicalTrials.gov ID
- NCT07866183
- Acronym / sponsor ID
- TIFFANY / 04-05/26
- Conditions
- Class I Obesity
- Keywords
- tirzepatide; Tirzetta; class I obesity; transcutaneous auricular vagus nerve stimulation; weight loss; epicardial adipose tissue; visceral adipose tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will include three groups: 30 participants with class I obesity receiving tirzepatide, 30 participants with class I obesity receiving transcutaneous auricular vagus nerve stimulation using HEALBE NEEM, and a 60-participant non-intervention control cohort consisting of 30 participants with normal body weight and 30 participants with class I obesity.
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide (Tirzetta) | Experimental | Drug: TirzepatideParticipants will receive Tirzetta according to the approved prescribing information. The source protocol does not specify a dose-escalation schedule. |
| HEALBE NEEM transcutaneous auricular vagus nerve stimulation device | Experimental | Device: Transcutaneous auricular vagus nerve stimulationThe 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. |
| Control Cohort | No intervention | –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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 25 to 50 years.
- Low cardiovascular risk according to the SCORE scale (SCORE <1%).
- Written informed consent to participate in the study
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideTirzepatide is administered to participants with Class I obesity according to the approved prescribing information throughtout the 24-week study | Drug | Tirzepatide (Tirzetta) |
| Transcutaneous auricular vagus nerve stimulationTranscutaneous 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 | Device | HEALBE NEEM transcutaneous auricular vagus nerve stimulation device |
Primary outcome
Percentage reduction in body weight
Time frame: Baseline, Week 8, Week 16, and Week 24.
Percentage change in body weight from baseline.
Percentage reduction in waist-to-height ratio
Time frame: Baseline, Week 8, Week 16, and Week 24
Percentage change in waist-to-height ratio from baseline
Percentage reduction in epicardial adipose tissue thickness
Time frame: Baseline and Week 24.
Percentage change in echocardiographically measured epicardial adipose tissue thickness from baseline
Percentage reduction in visceral adipose tissue
Time frame: Baseline and Week 24
Percentage change in visceral adipose tissue from baseline, assessed according to the study imaging protocol
8 secondary outcomes
Eating behavior - AEBQ
Time frame: Baseline and Week 24
Sleep quality - PSQI
Time frame: Baseline and Week 24
Perceived stress - PSS-10
Time frame: Baseline and Week 24
Anxiety and depression - HADS
Time frame: Baseline and Week 24
Alcohol use - AUDIT
Time frame: Baseline and Week 24
Cigarette consumption
Time frame: Baseline and Week 24
Left atrial reservoir strain
Time frame: Baseline and Week 24
Left ventricular reservoir strain
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Dzhioeva, MD, PhD, Professor study chair
National Medical Research Center for Therapy and Preventive Medicine
Oxana Drapkina, MD, DSc, Professor principal investigator
National Medical Research Center for Therapy and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tirzepatide and Transcutaneous auricular vagus nerve stimulation in people with Class I Obesity, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizaveta Rogozhkina, MD, PhD (+7 (937) 104-73-31, lizarogozkina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in body weight (time frame: Baseline, Week 8, Week 16, and Week 24.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.