NCT07619989 Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
| NCT ID | NCT07619989 |
| 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 | 2026-04-21 |
| Primary Completion | 2026-07-14 |
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 2026-04-21 with a primary completion date of 2026-07-14.
⚠ 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 is a single-center, randomized, participant-blinded, sham-controlled pilot 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.
Eligibility Criteria
Inclusion Criteria: 1. Individuals with obesity, or overweight accompanied by at least one weight-related comorbidity (e.g., hypertension or fatty liver disease), who have been receiving incretin receptor agonist therapy for at least 6 months and have achieved ≤10% weight loss during treatment; 2. 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, other than incretin receptor agonists, 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. Contraindications to MRI, such as metallic prostheses or claustrophobia; 6. Diagnosis of diabetes mellitus; Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.
Contact & Investigator
Yan Bi, MD, PhD
STUDY DIRECTOR
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Frequently Asked Questions
Who can join the NCT07619989 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 NCT07619989 currently recruiting?
Yes, NCT07619989 is actively recruiting participants. Contact the research team at biyan@nju.edu.cn for enrollment information.
Where is the NCT07619989 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07619989 clinical trial?
NCT07619989 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Yan Bi, MD, PhD at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University. The trial plans to enroll 24 participants.
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