ObesityNCT07319975
Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity
A study testing Semaglutide, Tirzepatide and Tirzepatide+Exercise in people with Obesity, run by Istanbul Galata University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide, Tirzepatide and Tirzepatide+Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Biruni University
Istanbul, Zeytinburnu
Buket Akinci, Associate Professor, PhD, +905056415692, bakinci@biruni.edu.tr
Fulya Calikoglu, PhD
About this study
Official title: Comparison of the Effects of Semaglutide and Tirzepatide Treatments in Combination With Exercise in Obesity Management
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
- Being tested
- Semaglutide, Tirzepatide, Tirzepatide+Exercise, Semaglutide+Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
They will use only semaglutide.
TirzepatideDrug
They will use only tirzepatide.
Tirzepatide+ExerciseBehavioural
This group will engage in exercise and receive tirzepatide therapy."
Semaglutide+ExerciseBehavioural
This group will engage in exercise and receive semaglutide therapy."
| Study group | Role | What they receive |
|---|---|---|
| ARM 1-Semaglutide | Experimental | Drug: Semaglutide Receives: Drug: Semaglutide |
| ARM 3-Semaglutide + Exercise | Experimental | Not described Receives: Behavioral: Semaglutide+Exercise |
| ARM 4-Tirzepatide + Exercise | Experimental | Not described Receives: Behavioral: Tirzepatide+Exercise |
| ARM 2-Tirzepatide | Experimental | Drug: Tirzepatide Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat-muscle ratios (Body composition)
These measurements will be determined by bioelectrical impedance.
Measured: Three months
Secondary outcomes (8)
Peripheral muscle strength
- Quadriceps muscle strength and hand grip strength measurement will be used to evaluate peripheral muscle strength (kg). Hand-held dynamometer will be used to evaluate quadriceps muscle strength and hand grip strength (kg).
Measured: Three months
Glucose profile
Glucose profile after 12 hours of fasting will be measured. (mg/dL)
Measured: Three months
Functional capacity
Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.
Measured: Three months
Pulmonary function
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1). Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).
Measured: Three months
Respiratory muscle strength
Respiratory muscle strength; It will be evaluated with an intraoral pressure measuring device in a sitting position.
Measured: Three months
Physical activity level
Step Count Measurement: Daily step count will be monitored to determine the physical activity level of the participants. Step count will be assessed with a wearable activity monitor, a portable, easy-to-use tool that can measure objectively (Huawei Watch Fit Special Edition). With its six-axis sensor, the device records the user's physical activity style information in its temporary memory throughout the duration of use. Participants will be asked to wear the activity monitor on their left wrist throughout and only remove it during bathing. After one week of use, the data recorded with the wearable activity monitor will be taken.
Measured: Three months
Incremental load test (Respiratory Muscle Endurance)
Respiratory muscle endurance will be evaluated by incremental load test. The incremental load test will be performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).
Measured: Three months
Lipid Profile
Lipid profile after 12 hours of fasting will be measured
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start29 Dec 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Galata University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University, Istanbul University
- Responsible party
- Principal investigator, Safak Yigit, Istanbul Galata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319975
- Sponsor's protocol ID
- 2025-GLP1-OBESITY
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Semaglutide and Tirzepatide Treatments in Combination With Exercise in Obesity Management
- ClinicalTrials.gov ID
- NCT07319975
- Acronym / sponsor ID
- 2025-GLP1-OBESITY
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul Galata UniversityUniversity, hospital or other
- Collaborators
- Biruni University, Istanbul University
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM 1-Semaglutide | Experimental | Drug: SemaglutideDrug: Semaglutide |
| ARM 3-Semaglutide + Exercise | Experimental | Behavioral: Semaglutide+Exercise |
| ARM 4-Tirzepatide + Exercise | Experimental | Behavioral: Tirzepatide+Exercise |
| ARM 2-Tirzepatide | Experimental | Drug: TirzepatideDrug: Tirzepatide |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideThey will use only semaglutide. | Drug | ARM 1-Semaglutide |
| TirzepatideThey will use only tirzepatide. | Drug | ARM 2-Tirzepatide |
| Tirzepatide+ExerciseThis group will engage in exercise and receive tirzepatide therapy." | Behavioural | ARM 4-Tirzepatide + Exercise |
| Semaglutide+ExerciseThis group will engage in exercise and receive semaglutide therapy." | Behavioural | ARM 3-Semaglutide + Exercise |
Primary outcome
Body fat-muscle ratios (Body composition)
Time frame: Three months
These measurements will be determined by bioelectrical impedance.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaglutide, Tirzepatide and Tirzepatide+Exercise in people with Obesity, run by Istanbul Galata University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safak Yigit, PhD (+905309634910, safak.yigit@galata.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat-muscle ratios (Body composition) (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.