Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity

Istanbul Galata University

Status: Not yet enrolling

Conditions: Obesity

Treatments: Drug: Semaglutide; Behavioral: Tirzepatide+Exercise; Drug: Tirzepatide; Behavioral: Semaglutide+Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07319975

2025-GLP1-OBESITY

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups

ARM 1-Semaglutide

Experimental group

Description:

Drug: Semaglutide

Treatment:

Drug: Semaglutide

ARM 3-Semaglutide + Exercise

Experimental group

Treatment:

Behavioral: Semaglutide+Exercise

ARM 4-Tirzepatide + Exercise

Experimental group

Treatment:

Behavioral: Tirzepatide+Exercise

ARM 2-Tirzepatide

Experimental group

Description:

Drug: Tirzepatide

Treatment:

Drug: Tirzepatide