Tirzepatide vs Liraglutide in Bone
ConditionObesity (Disorder)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-65
SponsorNational and Kapodistrian University of Athens
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adults aged between 30 and 65 years
BMI ≥40 kg/m²
Disqualifiers
Type 2 Diabetes Mellitus (T2DM) and type 1 Diabetes Mellitus (T1DM)
Chronic kidney disease
Liver failure
Heart failure
Trial population
This study involves patients with a body mass index (BMI) greater than 40 who either present for weight loss management at endocrinology or obesity clinics, or who are referred to sleep disorder centers due to obstructive sleep apnea syndrome requiring CPAP therapy, where weight loss intervention is consequently recommended.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
72 Participants
are grouped into 2 trial groupsGroup A: Liraglutide
Group B: Tirzepatide
Trial outcomes
Primary outcomes
1
Change in serum CTX concentration
Evaluation of changes in the bone resorption marker CTX at 3 months after intervention initiation in participants treated with tirzepatide versus liraglutide
Time frame
Baseline and 3 months after intervention initiationSecondary outcomes
1
Change in body weight
Evaluation of changes in body weight at 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide
Time frame
Baseline and 6 months after intervention initiation2
Change in Body Mass Index (BMI)
Evaluation of changes in BMI at 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide
Time frame
Baseline and 6 months after intervention initiation3
Change in Bone Mineral Density (BMD)
Evaluation of changes in BMD measured by DXA scan at 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide
Time frame
Baseline and 6 months after intervention initiation4
Change in Body Composition Parameters
Evaluation of changes in android fat mass, gynoid fat mass, android-to-gynoid fat ratio, trunk-to-legs fat percentage ratio, trunk-to-limb fat mass ratio, appendicular lean mass index and total fat mass measured by DXA whole-body scan at baseline and 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide
Time frame
Baseline and 6 months after intervention initiationSponsors and contacts
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National and Kapodistrian University of Athens
Lead sponsor
Laikο General Hospital, Athens
Collaborator
Athens Medical Center
Collaborator
Sotiria General Hospital
Collaborator
251 Hellenic Air Force & VA General Hospital
Collaborator
Evangelismos Hospital
Collaborator
Source ClinicalTrials.gov