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Enrolling by Invitation

NCT Number: NCT07041983

24-h Energy Expenditure and Anti-obesity Medication

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)

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

university hospital of Pisa

Pisa, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti obesity medication

Drug

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

Primary outcomes

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

    Time frame: Baseline and 6 months after treatment initiation

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

Secondary outcomes

  1. Change in body composition

    Time frame: Baseline and 6 months after treatment initiation

    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)

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: SEM-TIR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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