Tirzepatide vs Liraglutide in Bone

NCT07094568 | Recruiting

• 1 other identifier: 7130/23-05-25
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity (Disorder)

Keywords

obesity; bone metabolism; body composition; lean mass; free fat mass; fat mass; tirzepatide; liraglutide; CTX; P1NP

Outcome Measures

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

  Baseline and 3 months after intervention initiation

Secondary Outcomes (4)

• Change in body weight

  Baseline and 6 months after intervention initiation

• Change in Body Mass Index (BMI)

  Baseline and 6 months after intervention initiation

• Change in Bone Mineral Density (BMD)

  Baseline and 6 months after intervention initiation

• Change in Body Composition Parameters

  Baseline and 6 months after intervention initiation

Study Arms (2)

Liraglutide

Patients with obesity receiving liraglutide (up to maximum dose of 3mg daily)

Tirzepatide

Patients with obesity receiving tirzepatide (up to dose of 10-15mg weekly)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Adults aged between 30 and 65 years
• BMI ≥40 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Laikο General Hospital, Athens: collaborator
• Athens Medical Center: collaborator
• Sotiria General Hospital: collaborator
• 251 Hellenic Air Force & VA General Hospital: collaborator
• Evangelismos Hospital: collaborator

Study Sites (1)

Laiko General Hospital

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (36)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

blood (serum and plasma)

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maria Evangelia Koloutsou, Endocrinology Resident

CONTACT

+306986606272; mkoloutsou@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Endocrinologist in the 1st Department of Propaedeutic and Internal Medicine, Medical School of the National and Kapodistrian University of Athens (NKUA) and Deputy in Charge of (C.E.R.E.D) - Disorders of Calcium and Phosphate Metabolism

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 30, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)