DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07619989

RecruitingPhase NA

Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists

Adjunctive Transcutaneous Auricular Vagus Nerve Stimulation in Overweight or Obese Patients With a Suboptimal Weight-Loss Response to Incretin Receptor Agonists: A Single-Center, Randomized, Sham-Controlled Pilot Study

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

24

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body Weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07619989
Org study ID2026-0518-01

Timeline

Milestones

Study start2026-04-21actual
Study first posted2026-06-02actual
Last update posted2026-06-02actual
Primary completion2026-07-14estimated
Study completion2026-07-21estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Weight & body composition
4
Cardiometabolic biomarkers
4
Glycemic / diabetes
2
MASH / liver
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent Change in Body Weight From Baseline

Time frame:Baseline, 4 weeks, 8 weeks, 12 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline, Week 4, Week 8, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Composition and Fat Distribution

Time frame:Baseline, ,Week 4, Week 8, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Area

Time frame:Baseline, Week 4, Week 8, Week 12

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in blood glucose

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Glycated Hemoglobin

Time frame:Baseline, Week 12

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change in Liver Stiffness Measurement

Time frame:Baseline, Week 12

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in High-Density Lipoprotein Cholesterol

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Low-Density Lipoprotein Cholesterol

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Heart Rate Variability

Time frame:Baseline, Week 12

change from baseline, improvement

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Change in Hip Circumference

Time frame:Baseline, Week 4, Week 8, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Controlled Attenuation Parameter

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Liver Function

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Cardiovascular Autonomic Reflex Test Result

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Central Autonomic Network Functional Connectivity

Time frame:Baseline, Week 12

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Brain Biotype

Time frame:Baseline, Week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.