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NCT07619989
Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
Conditions: Obesity & Overweight
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Location: Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu
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. 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 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 \
Source: ClinicalTrials.gov (NCT07619989). StuddyBuddy aggregates publicly available trial information.