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SEM-TIR

Enrolling by invitation

24-h Energy Expenditure and Anti-obesity Medication

Effects of Anti-obesity Medications on 24h Energy Metabolism and Body Composition in Patients With Obesity

Lead sponsor

University of Pisa

Assets

Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

Enrollment

30

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

24h energy expenditure after 6 months of treatment

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 IDNCT07041983
Org study IDSEM-TIR
Secondary ID539901_2019_Santini_PRIN2017Italian Ministry of the University

Timeline

Milestones

Study first posted2025-06-27actual
Study start2025-07-01actual
Last update posted2026-05-05actual
Primary completion2026-06-01estimated
Study completion2026-12-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adults aged 18-75 years with Body mass index (BMI) \>= 30 kg/m² or \>= 27 kg/m² with at least one weight-related comorbidity (e.g., prediabetes, hypertension, dyslipidemia, sleep apnea, cardiovascular disease) and stable body weight (±2 kg in prior 3 months)

Inclusion criteria

Body mass index (BMI) >= 30 kg/m² or >= 27 kg/m² with at least one weight-related comorbidity and stable body weight (±2 kg in prior 3 months)
informed consent, adherence to study protocol, negative pregnancy test and contraception use (if applicable), and absence of cardiovascular events or end-organ damage.

Exclusion criteria

psychiatric conditions impairing adherence, history of medullary thyroid cancer, pregnancy/lactation
diabetes

Endpoints (2)

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

Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body composition

Time frame:Baseline and 6 months after treatment initiation

Total fat mass

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

change in 24h energy expenditure after 6 months of treatment

Time frame:Baseline and 6 months after treatment initiation

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.