NCT07630597 Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention
| NCT ID | NCT07630597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Obesity & Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-05-08 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period; 2. Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period; 3. 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); 4. Willingness to provide written informed consent. Exclusion Criteria: 1. 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; 2. Use within the past 3 months of medications that may significantly affect body weight, including glucocorticoids and antipsychotic agents; 3. Skin infection or damage involving the auricular area; 4. Women planning pregnancy in the near future; 5. Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07630597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Obesity & Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07630597 currently recruiting?
Yes, NCT07630597 is actively recruiting participants. Contact the research team at biyan@nju.edu.cn for enrollment information.
Where is the NCT07630597 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07630597 clinical trial?
NCT07630597 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 24 participants.
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