Transcutaneous auricular vagus nerve stimulation added to tirzepatide for poor weight loss responses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a single center, randomized, participant-blinded, sham-controlled design, 24 adults with obesity or overweight on tirzepatide who have not achieved adequate weight loss will be assigned to taVNS plus tirzepatide or sham stimulation plus tirzepatide for 12 weeks. Participants will undergo baseline and follow-up assessments of weight, body composition, autonomic function, and liver health, including MR imaging and FibroTouch, with ongoing remote monitoring of device use and weekly weight checks. The primary outcome is the between-group difference in percent weight change at week 12; secondary outcomes include changes in body composition, fat distribution, and metabolic markers. The trial seeks to determine if adjunct taVNS can enhance weight loss achieved with incretin receptor agonist therapy.

Why it matters

Who can join: the full rules

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 tirzepatide therapy for at least 12 weeks 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.

Where it's running

• Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yan Bi, MD, PhD
• Email: biyan@nju.edu.cn
• Phone: 6-25-83-105302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.