Obesity & OverweightNCT07630597
Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention
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.
Trial summary
This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight/obese patients who show a poor weight loss response to lifestyle intervention. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 31 Mar 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
- Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;
- Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;
- Current body mass index (BMI) ≥28 kg/m², or BMI ≥24 kg/m² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease);
- 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 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;
- 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.
Tian Wei Gu, MD, PhD contact
China1 site, 1 recruiting
- 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
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight/Obese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study
This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight/obese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
Read the detailed description
Obesity is a chronic metabolic disease with substantial health consequences, and lifestyle intervention remains the foundation of weight management. However, a considerable proportion of overweight or obese individuals fail to achieve clinically meaningful weight loss after structured lifestyle intervention. In this study, patients with poor response to lifestyle intervention are defined as those who have completed 12 weeks of lifestyle intervention with weight loss of 5% or less.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that stimulates the auricular branch of the vagus nerve and may improve autonomic balance, appetite regulation, and energy metabolism. This study is designed to investigate whether taVNS can enhance weight loss and improve metabolic outcomes when used as an adjunct to lifestyle intervention in overweight/obese patients with poor early response.
A total of 24 participants will be enrolled at a single center and randomized in a 1:1 ratio to either the taVNS plus lifestyle intervention group or the sham stimulation plus lifestyle intervention group. The intervention period will last 12 weeks. All participants will receive standardized lifestyle guidance including dietary management and exercise management. Dietary intervention will be individualized based on basal metabolic rate measured by InBody and guided by the Dietary Guidelines for Chinese Residents, with an intended daily energy deficit of approximately 500 kcal. Exercise management will require at least 3 days of moderate-to-high intensity physical activity per week, with a total duration of at least 150 minutes, monitored by a wearable device.
Participants in the active treatment group will receive taVNS applied to the left cymba conchae using an intermittent electrical stimulation pattern (15 seconds on, 5 seconds off), frequency of 20 Hz, pulse width of 0.2 ms, and intensity gradually increased to a tolerable mild tingling sensation, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes each time, 5 times per week, for 12 weeks. Participants in the control group will receive sham stimulation at the left tail of the helix, with the same stimulation schedule and device settings.
Assessments will be performed at baseline and after 12 weeks of intervention, including anthropometric measurements, body composition analysis, autonomic function testing, laboratory testing, and evaluation of hepatic steatosis and fibrosis using FibroTouch and liver MRI. The primary endpoint is percent change in body weight from baseline at week 12. Secondary endpoints include changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
- Conditions
- Obesity & Overweight
- Being tested
- transcutaneous auricular vagus nerve stimulation, Sham
- Keywords
- Obesity & Overweight, Transcutaneous Auricular Vagus Nerve Stimulation, Lifestyle Intervention, 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 Lifestyle Intervention
Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle Intervention for 12 weeks. Active stimulation will be delivered to the left cymba conchae using an intermittent waveform (15 seconds on, 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.
ShamDevice
Also called Lifestyle Intervention
Participants will receive sham stimulation in addition to lifestyle Intervention for 12 weeks. Sham stimulation will be applied to the left tail of the helix using 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.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Plus Lifestyle Intervention | Experimental | Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle intervention for 12 weeks. Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Sham Stimulation plus Lifestyle Intervention | Sham comparator | Participants will receive sham stimulation in addition to standardized lifestyle intervention for 12 weeks Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline
Percent change in body weight from baseline to week 12 will be compared between the taVNS plus lifestyle intervention group and the sham stimulation plus lifestyle intervention group to evaluate the adjunctive effect of taVNS on weight reduction.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (15)
Change in Waist Circumference
Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement.
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
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
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
Change in blood glucose
Change in fasting blood glucose from baseline to Week 12 will be assessed using laboratory testing.
Measured: Baseline, Week 12
Change in Glycated Hemoglobin
Change in glycated hemoglobin (HbA1c) from baseline to Week 12 will be assessed using laboratory testing.
Measured: Baseline, Week 12
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
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
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
Change in Triglycerides
Change in triglycerides from baseline to Week 12 will be assessed using laboratory testing.
Measured: Baseline, Week 12
Change in Insulin Resistance
Change in insulin resistance from baseline to Week 12 will be assessed using the homeostatic model assessment of insulin resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels.
Measured: Baseline, Week 12
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
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
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start8 May 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630597
- Sponsor's protocol ID
- 2026-0518-02
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 5 Jun 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight/Obese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07630597
- Acronym / sponsor ID
- 2026-0518-02
- Conditions
- Obesity & Overweight
- Keywords
- Obesity & Overweight, Transcutaneous Auricular Vagus Nerve Stimulation, Lifestyle Intervention, Non-responders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Jun 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, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight/obese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
Detailed description
Obesity is a chronic metabolic disease with substantial health consequences, and lifestyle intervention remains the foundation of weight management. However, a considerable proportion of overweight or obese individuals fail to achieve clinically meaningful weight loss after structured lifestyle intervention. In this study, patients with poor response to lifestyle intervention are defined as those who have completed 12 weeks of lifestyle intervention with weight loss of 5% or less.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that stimulates the auricular branch of the vagus nerve and may improve autonomic balance, appetite regulation, and energy metabolism. This study is designed to investigate whether taVNS can enhance weight loss and improve metabolic outcomes when used as an adjunct to lifestyle intervention in overweight/obese patients with poor early response.
A total of 24 participants will be enrolled at a single center and randomized in a 1:1 ratio to either the taVNS plus lifestyle intervention group or the sham stimulation plus lifestyle intervention group. The intervention period will last 12 weeks. All participants will receive standardized lifestyle guidance including dietary management and exercise management. Dietary intervention will be individualized based on basal metabolic rate measured by InBody and guided by the Dietary Guidelines for Chinese Residents, with an intended daily energy deficit of approximately 500 kcal. Exercise management will require at least 3 days of moderate-to-high intensity physical activity per week, with a total duration of at least 150 minutes, monitored by a wearable device.
Participants in the active treatment group will receive taVNS applied to the left cymba conchae using an intermittent electrical stimulation pattern (15 seconds on, 5 seconds off), frequency of 20 Hz, pulse width of 0.2 ms, and intensity gradually increased to a tolerable mild tingling sensation, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes each time, 5 times per week, for 12 weeks. Participants in the control group will receive sham stimulation at the left tail of the helix, with the same stimulation schedule and device settings.
Assessments will be performed at baseline and after 12 weeks of intervention, including anthropometric measurements, body composition analysis, autonomic function testing, laboratory testing, and evaluation of hepatic steatosis and fibrosis using FibroTouch and liver MRI. The primary endpoint is percent change in body weight from baseline at week 12. Secondary endpoints include changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS Plus Lifestyle Intervention | Experimental | Device: transcutaneous auricular vagus nerve stimulationParticipants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle intervention for 12 weeks. |
| Sham Stimulation plus Lifestyle Intervention | Sham comparator | Device: ShamParticipants will receive sham stimulation in addition to standardized lifestyle intervention for 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;
- Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;
- Current body mass index (BMI) ≥28 kg/m², or BMI ≥24 kg/m² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease);
- Willingness to provide written informed consent.
Key exclusion criteria (5 listed)
- 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 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;
- Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.
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 |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationAlso: Lifestyle InterventionParticipants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle Intervention for 12 weeks. Active stimulation will be delivered to the left cymba conchae using an intermittent waveform (15 seconds on, 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. | Device | taVNS Plus Lifestyle Intervention |
| ShamAlso: Lifestyle InterventionParticipants will receive sham stimulation in addition to lifestyle Intervention for 12 weeks. Sham stimulation will be applied to the left tail of the helix using 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. | Device | Sham Stimulation plus Lifestyle Intervention |
Primary outcome
Percent Change in Body Weight From Baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Percent change in body weight from baseline to week 12 will be compared between the taVNS plus lifestyle intervention group and the sham stimulation plus lifestyle intervention group to evaluate the adjunctive effect of taVNS on weight reduction.
15 secondary outcomes
Change in Waist Circumference
Time frame: Baseline, ,Week 4, Week 8, Week 12
Change in Body Composition and Fat Distribution
Time frame: Baseline, ,Week 4, Week 8, Week 12
Change in Visceral Fat Area
Time frame: Baseline, ,Week 4, Week 8, Week 12
Change in blood glucose
Time frame: Baseline, Week 12
Change in Glycated Hemoglobin
Time frame: Baseline, Week 12
Change in Hip Circumference
Time frame: Baseline, ,Week 4, Week 8, Week 12
Change in High-Density Lipoprotein Cholesterol
Time frame: Baseline, Week 12
Change in Low-Density Lipoprotein Cholesterol
Time frame: Baseline, Week 12
Change in Triglycerides
Time frame: Baseline, Week 12
Change in Insulin Resistance
Time frame: Baseline, Week 12
Change in Controlled Attenuation Parameter
Time frame: Baseline, Week 12
Change in Liver Stiffness Measurement
Time frame: Baseline, Week 12
Change in Liver Function
Time frame: Baseline, Week 12
Change in Heart Rate Variability
Time frame: Baseline, Week 12
Change in Cardiovascular Autonomic Reflex Test Result
Time frame: Baseline, Week 12
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 5 Jun 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.
Tian Wei Gu, MD, PhD contact
1 site in 1 country: see every site and its status.
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 4 inclusion and 5 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 5 Jun 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 5 Jun 2026.