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Not yet recruiting NCT07319975

Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide, Tirzepatide, Tirzepatide+Exercise, Semaglutide+Exercise.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 25 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of the Effects of Semaglutide and Tirzepatide Treatments in Combination With Exercise in Obesity Management

Overview

Obesity is a growing global health problem that affects people of all ages. It can lead to serious health issues such as cardiovascular disease, insulin resistance, inflammation, and reduced physical function. New medications, including GLP-1 receptor agonists like semaglutide and dual GLP-1/GIP agonists like tirzepatide, have been shown to help people lose significant weight. However, some of this rapid weight loss may come from a reduction in muscle mass rather than fat. Losing muscle can lower physical performance, impair metabolic health, and increase the risk of developing sarcopenic obesity. This study aims to compare the effects of pharmacological treatment alone with a combined treatment program that includes both medication and exercise in individuals with obesity. The primary objective is to evaluate how these two approaches influence body composition. The secondary objective is to examine the effects of pharmacological treatment versus combined treatment on cardiometabolic markers, peripheral muscle strength, functional capacity, respiratory function, respiratory muscle performance, and physical activity levels. The study seeks to determine whether adding structured exercise to medication can provide additional health benefits beyond weight loss.

Interventions

  • Drug Semaglutide
    They will use only semaglutide.
  • Drug Tirzepatide
    They will use only tirzepatide.
  • Behavioral Tirzepatide+Exercise
    This group will engage in exercise and receive tirzepatide therapy."
  • Behavioral Semaglutide+Exercise
    This group will engage in exercise and receive semaglutide therapy."

Primary outcome measures

  • Body fat-muscle ratios (Body composition) [Time frame: Three months]
Secondary outcome measures (8)
  • Peripheral muscle strength [Time frame: Three months]
  • Glucose profile [Time frame: Three months]
  • Functional capacity [Time frame: Three months]
  • Pulmonary function [Time frame: Three months]
  • Respiratory muscle strength [Time frame: Three months]
  • Physical activity level [Time frame: Three months]
  • Incremental load test (Respiratory Muscle Endurance) [Time frame: Three months]
  • Lipid Profile [Time frame: Three months]

Eligibility criteria

Inclusion criteria

  • Those between the ages of 25 and 60 years
  • Those with a body mass index (BMI) between 30 and 40 kg/m2 according to the World Health Organization (WHO) classification
  • Individuals who volunteered to participate in the study

Exclusion criteria

  • Individuals with a BMI greater than 40 kg/m2 according to the WHO classification
  • Individuals with a Charlson comorbidity index score of 3 or higher
  • Uncontrolled arrhythmia, hypertension, heart failure, diabetes, and unstable angina pectoris
  • Cooperation impairment, orthopedic, and neurological problems that may interfere with evaluation and treatment
  • Individuals with a history of lower extremity injury or surgery in the last six months
  • Diagnosed with diabetes and complications such as nephropathy, retinopathy, and neuropathy
  • Individuals with concomitant chronic respiratory disease
  • Individuals with acute infections
  • Individuals with middle ear pathologies (such as tympanic membrane rupture, otitis media)
  • Individuals with a history of spontaneous or trauma-related pneumothorax
  • Smokers
  • Pregnancy
  • Individuals with a STOP-bang score of 3 or higher
  • Individuals on a structured diet program for weight loss during the study period
  • Individuals who have had endoscopic intervention and/or bariatric surgery within the last year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Biruni University — Istanbul

Identifiers

NCT: NCT07319975 · 2025-GLP1-OBESITY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗