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TIFFANY

RecruitingPhase NA

Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Estimated enrollment

120

Study population

Obesity / overweight

Eligibility highlights

-

Primary endpoints

•Body weight•Waist-to-height ratio•Epicardial adipose tissue thickness

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07866183
Org study ID04-05/26

Timeline

Milestones

Study start2026-06-29actual
Study first posted2026-10-08actual
Last update posted2026-10-08actual
Primary completion2027-06estimated (month precision)
Study completion2027-08estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age25 Years
Maximum age50 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Age 25 to 50 years.
•Low cardiovascular risk according to the SCORE scale (SCORE <1%).
•Written informed consent to participate in the study

Exclusion criteria

•Cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree.
•For participants in the obesity cohorts: body mass index greater than or equal to 35 kg/m². Participants with normal body weight may be enrolled in the designated normal-weight control subgroup.
•Expected technical difficulties with use of the stimulation device by the participant.
•Any acute disease or chronic disease in the stage of exacerbation and/or decompensation.

Endpoints (12)

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)
8
Weight & body composition
4

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percentage reduction in body weight

Time frame:Baseline, Week 8, Week 16, and Week 24.

change from baseline, improvement

Primary/protocol endpoint

Percentage reduction in waist-to-height ratio

Time frame:Baseline, Week 8, Week 16, and Week 24

change from baseline, improvement

Primary/protocol endpoint

Percentage reduction in epicardial adipose tissue thickness

Time frame:Baseline and Week 24.

change from baseline, improvement

Primary/protocol endpoint

Percentage reduction in visceral adipose tissue

Time frame:Baseline and Week 24

change from baseline, improvement

Other (unclassified)

8 endpoints
Secondary/protocol endpoint/low confidence

Eating behavior - AEBQ

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Sleep quality - PSQI

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Perceived stress - PSS-10

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Anxiety and depression - HADS

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Alcohol use - AUDIT

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Cigarette consumption

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Left atrial reservoir strain

Time frame:Baseline and Week 24

descriptive

Secondary/protocol endpoint/low confidence

Left ventricular reservoir strain

Time frame:Baseline and Week 24

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.