Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity

NCT07319975 | Not Yet Recruiting

• 1 other identifier: 2025-GLP1-OBESITY
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body fat-muscle ratios (Body composition)

  These measurements will be determined by bioelectrical impedance.

  Three months

Secondary Outcomes (8)

• Peripheral muscle strength

  Three months

• Glucose profile

  Three months

• Functional capacity

  Three months

• Pulmonary function

  Three months

• Respiratory muscle strength

  Three months

Study Arms (4)

ARM 1-Semaglutide

EXPERIMENTAL

Drug: Semaglutide

Drug: Semaglutide

ARM 3-Semaglutide + Exercise

EXPERIMENTAL

Behavioral: Semaglutide+Exercise

ARM 4-Tirzepatide + Exercise

EXPERIMENTAL

Behavioral: Tirzepatide+Exercise

ARM 2-Tirzepatide

EXPERIMENTAL

Drug: Tirzepatide

Drug: Tirzepatide

Interventions

Semaglutide DRUG

They will use only semaglutide.

ARM 1-Semaglutide

Tirzepatide DRUG

They will use only tirzepatide.

ARM 2-Tirzepatide

Tirzepatide+Exercise BEHAVIORAL

This group will engage in exercise and receive tirzepatide therapy."

ARM 4-Tirzepatide + Exercise

Semaglutide+Exercise BEHAVIORAL

This group will engage in exercise and receive semaglutide therapy."

ARM 3-Semaglutide + Exercise

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Galata University: lead
• Biruni University: collaborator
• Istanbul University: collaborator

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide; Tirzepatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Safak Yigit, PhD

CONTACT

+905309634910; safak.yigit@galata.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 6, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)