ClinicalTrials.gg
Enrolling by invitationNCT07041983SEM-TIRUpdated May 5, 2026

24-h Energy Expenditure and Anti-obesity Medication

An observational study in Obesity, sponsored by University of Pisa. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Pisa · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study investigates the long-term effects of anti-obesity medications (Semaglutide and Tirzepatide) on energy metabolism (24-hour energy expenditure and substrate oxidation) and body composition via Dual-energy X-ray absorptiometry (DXA)

Read the detailed description

This study will explore the long-term effects of obesity treatments, including anti-obesity medications (AOMs) such as GLP-1 receptor agonist (Semaglutide) and GIP/GLP-1 receptor agonist (Tirzepatide), on energy metabolism (24-hour energy expenditure and substrate oxidation), body composition (fat mass and fat-free mass). The study will include AOMs may lead to a state of metabolic adaptation, one of the reasons for weight regain. To date, no studies have assessed the effects of AOMs on 24-hour energy expenditure measured by using the metabolic chamber.

02

Conditions studied

  • Obesity

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Keywords

  • energy metabolism
  • body composition
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 30 is below the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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)
  • , adherence to study protocol, negative pregnancy test and use (if applicable), and absence of cardiovascular events or end-organ damage.

Exclusion criteria

Exclusion Criteria:

  • psychiatric conditions impairing adherence, history of medullary thyroid cancer, pregnancy/lactation
  • diabetes
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • antiobesity medication and energy expenditure

    patients with obesity for the administration anti-obesity medication (Semaglutide or Tirzepatide) for the clinical use.

    Drug: anti obesity medication

Interventions

  • Druganti obesity medication

    Patients with obesity or overweight, with at least one weight-related comorbidity who are expected to start treatment with Semaglutide (Wegovy) or Terzepatide (Mounjaro) at enrolment will be eligible to enrol into the study. Patients will be treated and observed according to normal clinical practice. Participation in this study does not limit the physicians' clinical decision making as to the most appropriate treatment for the patient during the course of the study

This study also gives Semaglutide, Tirzepatide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. change in 24h energy expenditure after 6 months of treatment

    measurement of 24-hour energy expenditure (kilocalories) by using the metabolic chamber (whole room indirect calorimeter) at baseline and after 6 months of treatment

    Time frame: Baseline and 6 months after treatment initiation

Secondary outcomes

  1. Change in body composition

    Quantification of variations in fat mass and fat-free mass (kg) following 6 months of therapy, as determined by Dual-Energy X-ray Absorptiometry (DEXA)

    Time frame: Baseline and 6 months after treatment initiation

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 11 months is below that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2025
First posted
Jun 27, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Jun 1, 2026
CompletionEst.
Dec 1, 2026
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07041983
Lead sponsor
University of Pisa
Responsible party
Alessio Basolo (Researcher, University of Pisa) — Principal investigator
First posted
Jun 27, 2025
Start date
Jul 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
May 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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