| NCT ID | NCT07094568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Obesity (Disorder) |
| Study Type | OBSERVATIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 72 participants in total. It began in 2025-05-23 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective cohort study investigates the effects of tirzepatide versus liraglutide on bone turnover markers and body composition in adults with class 3 obesity, characterised by Body Mass Index (BMI) ≥40 kg/m². Participants will be followed for 6 months with assessments at baseline, 3 and 6. The primary outcome is the change in bone resorption marker C-terminal telopeptide of type I collagen (CTX) at 3 months. Secondary outcomes include changes in body weight, BMI, bone mineral density (BMD), and body composition. The study aims to clarify the differential impact of weight loss achieved through tirzepatide versus liraglutide on bone metabolism and body composition in adults with obesity.
Eligibility Criteria
Inclusion Criteria: * Adults aged between 30 and 65 years * BMI ≥40 kg/m² Exclusion Criteria: * Type 2 Diabetes Mellitus (T2DM) and type 1 Diabetes Mellitus (T1DM) * Chronic kidney disease * Liver failure * Heart failure * Malignancy coexistence * Previous bariatric or gastrointestinal surgery involving intestinal bypass * Uncontrolled hypo/hyperthyroidism * Uncontrolled hypo/hyperparathyroidism * Pregnancy and lactation * Recent fracture (within 2 years) * Rare Metabolic Bone Diseases (e.g., Paget's disease of bone, fibrous dysplasia, osteopetrosis) * Inflammatory arthritis * Medications which can affect bone markers: bone-anabolic agents, antiresorptive agents, antiandrogenic agents, vitamin K antagonists, antipsychotic agents, contraceptives, glucocorticoids (oral), methotrexate, thiazides, aromatase inhibitors etc) * Hemolytic anemia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07094568 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Obesity (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07094568 currently recruiting?
Yes, NCT07094568 is actively recruiting participants. Contact the research team at mkoloutsou@yahoo.com for enrollment information.
Where is the NCT07094568 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07094568 clinical trial?
NCT07094568 is sponsored by National and Kapodistrian University of Athens. The trial plans to enroll 72 participants.
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