AzTrials
AzTrials

Obesity & OverweightNCT07619989

Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists

A study testing transcutaneous auricular vagus nerve stimulation in people with Obesity & Overweight, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-center, randomized, participant-blinded, sham-controlled trial designed to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight or obese patients who show a suboptimal weight-loss response to incretin receptor agonist therapy. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obesity & Overweight
What is being tested?
transcutaneous auricular vagus nerve stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteChina
Study dates
1 Aug 2026to 1 Sep 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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Individuals with obesity, or overweight accompanied by at least one weight-related comorbidity (e.g., hypertension or fatty liver disease), who have been receiving tirzepatide therapy for at least 12 weeks and have achieved ≤10% weight loss during treatment;
  • Willingness to provide written informed consent.

Who cannot join

  • Presence of diseases that may substantially affect body weight homeostasis, including Cushing's syndrome, uncontrolled thyroid disease (thyroid-stimulating hormone >6.0 mIU/L or <0.4 mIU/L), malignancy, or similar conditions;
  • Use within the past 3 months of medications, other than incretin receptor agonists, that may significantly affect body weight, including glucocorticoids and antipsychotic agents;
  • Skin infection or damage involving the auricular area;
  • Women planning pregnancy in the near future;
  • Contraindications to MRI, such as metallic prostheses or claustrophobia;
  • Diagnosis of diabetes mellitus; Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Yan Bi, MD,PhD, 6-25-83-105302, biyan@nju.edu.cn

    Tian Wei Gu, MD, PhD, (86) 25-83106666 ext. (86) 25-831066, gtw0235@163.com

    Recruiting

Other trials in China

About this study

Official title: Adjunctive Transcutaneous Auricular Vagus Nerve Stimulation in Overweight or Obese Patients With a Suboptimal Weight-Loss Response to Incretin Receptor Agonists: A Single-Center, Randomized, Sham-Controlled Study

This is a single-center, randomized, participant-blinded, sham-controlled trial designed to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight or obese patients who show a suboptimal weight-loss response to incretin receptor agonist therapy. A total of 24 participants will be randomly assigned to receive either taVNS plus tirzepatide 5 mg or sham stimulation plus tirzepatide 5 mg for 12 weeks. The primary objective is to compare the percent change in body weight from baseline to week 12 between the two groups.

Read the detailed description

This is a prospective, single-center, randomized, participant-blinded, sham-controlled, parallel-group study conducted at the Department of Endocrinology, Nanjing Drum Tower Hospital. The study will enroll 24 overweight or obese participants with a suboptimal weight-loss response, defined as a body weight reduction of no more than 10% after at least 12 weeks of tirzepatide treatment. Eligible participants will be randomized in a 1:1 ratio to the taVNS plus tirzepatide 5 mg group or the sham stimulation plus tirzepatide 5 mg group for 12 weeks.

Before and after intervention, all participants will undergo standardized assessments, including lifestyle questionnaires, anthropometric measurements, body composition analysis, autonomic function evaluation, laboratory testing, and assessment of hepatic steatosis and fibrosis. Autonomic function assessment will include heart rate variability, cardiovascular autonomic reflex tests, sudomotor function, and brain MRI. Liver-related assessments will include FibroTouch and liver MRI. During follow-up, body weight will be monitored weekly by telephone or WeChat, waist circumference, hip circumference, and body composition will be reassessed every 4 weeks, and device use will be monitored through an app to ensure adherence and protocol consistency.

The primary endpoint is the between-group difference in percent change in body weight from baseline to week 12. Secondary endpoints include changes in body composition and fat distribution, glucose- and lipid-related metabolic parameters, liver function and hepatic steatosis/fibrosis-related parameters, and autonomic function measures. Exploratory analyses will evaluate changes in brain imaging phenotypes after 12 weeks of intervention.

Being tested
transcutaneous auricular vagus nerve stimulation, Sham
Keywords
Obesity & Overweight, Transcutaneous Auricular Vagus Nerve Stimulation, Incretin Receptor Agonists, Non-responders
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous auricular vagus nerve stimulationDevice

    Also called tirzepatide 5 mg

    Participants will receive active transcutaneous auricular vagus nerve stimulation plus tirzepatide 5 mg for 12 weeks. Active stimulation will be delivered to the bilateral cymba conchae, an auricular region innervated by the auricular branch of the vagus nerve. Stimulation will use an intermittent waveform of 15 seconds on and 5 seconds off at 20 Hz, with a pulse width of 0.2 ms. Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks. Tirzepatide will be administered as a subcutaneous injection once weekly.

  • ShamDevice

    Also called tirzepatide 5 mg

    Participants will receive sham stimulation in addition to tirzepatide 5 mg for 12 weeks. Sham stimulation will be applied to the bilateral tail of the helix, an auricular site without vagus nerve distribution, whereas active taVNS targets the cymba conchae, which is innervated by the auricular branch of the vagus nerve. The sham group will use the same waveform parameters, stimulation intensity titration, and treatment schedule as the active group, namely twice daily for 30 minutes per session, 5 days per week, for 12 weeks. Tirzepatide will be administered as a subcutaneous injection once weekly.

Study groups in NCT07619989
Study groupRoleWhat they receive
taVNS Plus Tirzepatide 5 mgExperimentalParticipants will receive active transcutaneous auricular vagus nerve stimulation plus tirzepatide 5 mg for 12 weeks. Active stimulation will be delivered to the bilateral cymba conchae, an auricular region innervated by the auricular branch of the vagus nerve. Stimulation will use an intermittent waveform of 15 seconds on and 5 seconds off at 20 Hz, with a pulse width of 0.2 ms. Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks. Tirzepatide will be administered as a subcutaneous injection once weekly.
Receives: Device: transcutaneous auricular vagus nerve stimulation
Sham Stimulation Plus Tirzepatide 5 mgSham comparatorParticipants will receive sham stimulation in addition to tirzepatide 5 mg for 12 weeks. Sham stimulation will be applied to the bilateral tail of the helix, an auricular site without vagus nerve distribution, whereas active taVNS targets the cymba conchae, which is innervated by the auricular branch of the vagus nerve. The sham group will use the same waveform parameters, stimulation intensity titration, and treatment schedule as the active group, namely twice daily for 30 minutes per session, 5 days per week, for 12 weeks. Tirzepatide will be administered as a subcutaneous injection once weekly.
Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Body Weight From Baseline

    Percent change in body weight from baseline to week 12 will be compared between the taVNS plus tirzepatide group and the sham stimulation plus tirzepatide group to evaluate the adjunctive effect of taVNS on weight reduction.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (15)
  1. Change in Waist Circumference

    Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement.

    Measured: Baseline, Week 4, Week 8, Week 12

  2. Change in Body Composition and Fat Distribution

    Changes in body composition and fat distribution will be assessed by body fat percentage using anthropometric measurements and body composition analysis.

    Measured: Baseline, ,Week 4, Week 8, Week 12

  3. Change in blood glucose

    Change in fasting blood glucose from baseline to Week 12 will be assessed using laboratory testing.

    Measured: Baseline, Week 12

  4. Change in Hip Circumference

    Change in hip circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement.

    Measured: Baseline, Week 4, Week 8, Week 12

  5. Change in Visceral Fat Area

    Change in visceral fat area from baseline to Week 4, Week 8, and Week 12 will be assessed using body composition analysis.

    Measured: Baseline, Week 4, Week 8, Week 12

  6. Change in Glycated Hemoglobin

    Change in glycated hemoglobin (HbA1c) from baseline to Week 12 will be assessed using laboratory testing.

    Measured: Baseline, Week 12

  7. Change in High-Density Lipoprotein Cholesterol

    Change in high-density lipoprotein cholesterol (HDL-C) from baseline to Week 12 will be assessed using laboratory testing.

    Measured: Baseline, Week 12

  8. Change in Low-Density Lipoprotein Cholesterol

    Change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 12 will be assessed using laboratory testing.

    Measured: Baseline, Week 12

  9. Change in Triglycerides

    Change in triglycerides from baseline to Week 12 will be assessed using laboratory testing.

    Measured: Baseline, Week 12

  10. Change in Controlled Attenuation Parameter

    Change in controlled attenuation parameter (CAP) from baseline to Week 12 will be assessed using transient elastography.

    Measured: Baseline, Week 12

  11. Change in Liver Stiffness Measurement

    Change in liver stiffness measurement (LSM) from baseline to Week 12 will be assessed using transient elastography.

    Measured: Baseline, Week 12

  12. Change in Liver Function

    Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline to Week 12 will be assessed using laboratory testing.

    Measured: Baseline, Week 12

  13. Change in Heart Rate Variability

    Change in heart rate variability from baseline to Week 12 will be assessed using time-domain and/or frequency-domain heart rate variability analysis.

    Measured: Baseline, Week 12

  14. Change in Cardiovascular Autonomic Reflex Test Result

    Change in cardiovascular autonomic reflex function from baseline to Week 12 will be assessed using standardized cardiovascular autonomic reflex testing.

    Measured: Baseline, Week 12

  15. Change in Central Autonomic Network Functional Connectivity

    Change in central autonomic network features from baseline to Week 12 will be assessed using brain MRI-based functional connectivity analysis.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07619989
Sponsor's protocol ID
2026-0518-01
Status last verified
Jul 2026
First submitted
18 May 2026
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous auricular vagus nerve stimulation in people with Obesity & Overweight, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

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 2 inclusion and 6 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 31 Jul 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 China. 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. Some participants in this study may receive a placebo. 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 Yan Bi, MD, PhD (6-25-83-105302, biyan@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Weight From Baseline (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). 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 31 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in