TiLi-BONE

Recruiting

Tirzepatide vs Liraglutide in Bone

Comparative Investigation of Changes in Body Composition and Bone Turnover Markers in People With Obesity After Treatment With Tirzepatide Versus Liraglutide. A Prospective Cohort Study.

Lead sponsor

National and Kapodistrian University of Athens

Assets

Liraglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥40

Primary endpoint

•Serum CTX concentration

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07094568

Org study ID7130/23-05-25

Timeline

Milestones

Study start2025-05-23actual

Study first posted2025-07-30actual

Last update posted2026-01-21actual

Primary completion2026-12-30estimated

Study completion2026-12-30estimated

Assets

Investigational agents

Liraglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age30 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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.

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline and 6 months after intervention initiation

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline and 6 months after intervention initiation

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Bone Mineral Density (BMD)

Time frame:Baseline and 6 months after intervention initiation

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Composition Parameters

Time frame:Baseline and 6 months after intervention initiation

change from baseline, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Change in serum CTX concentration

Time frame:Baseline and 3 months after intervention initiation

change from baseline, descriptive

Publications (36)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

The Treatment and Monitoring of Osteoporosis using Bone Turnover Markers.
Orthopedic reviews2025 (year)PMID39790440doi:10.52965/001c.127772via CT.gov reference
Effects of Semaglutide and Tirzepatide on Bone Metabolism in Type 2 Diabetic Mice.
Pharmaceuticals (Basel, Switzerland)2024 Dec 9PMID39770498doi:10.3390/ph17121655via CT.gov reference
The impact of weight loss on fat-free mass, muscle, bone and hematopoiesis health: Implications for emerging pharmacotherapies aiming at fat reduction and lean mass preservation.
Metabolism: clinical and experimental2024 Dec (month)PMID39481534doi:10.1016/j.metabol.2024.156057via CT.gov reference
Changes in bone turnover markers 6-12 months after bariatric surgery.
Scientific reports2024 Jun 27PMID38937532doi:10.1038/s41598-024-65952-yvia CT.gov reference
Clinical use of bone markers: a challenge to variability.
Advances in laboratory medicine2024 Mar (month)PMID38634081doi:10.1515/almed-2023-0092via CT.gov reference
Association between waist-to-height ratio and osteoporosis in the National Health and Nutrition Examination Survey: a cross-sectional study.
Frontiers in medicine2024 (year)PMID39744530doi:10.3389/fmed.2024.1486611via CT.gov reference
Effect of Liraglutide on Osteoporosis in a Rat Model of Type 2 Diabetes Mellitus: A Histological, Immunohistochemical, and Biochemical Study.
Microscopy and microanalysis : the official journal of Microscopy Society of America, Microbeam Analysis Society, Microscopical Society of Canada2023 Dec 21PMID37832035doi:10.1093/micmic/ozad102via CT.gov reference
The effect of overweight or obesity on osteoporosis: A systematic review and meta-analysis.
Clinical nutrition (Edinburgh, Scotland)2023 Dec (month)PMID37925778doi:10.1016/j.clnu.2023.10.013via CT.gov reference
Bone Turnover Markers: Basic Biology to Clinical Applications.
Endocrine reviews2023 May 8PMID36510335doi:10.1210/endrev/bnac031via CT.gov reference
Antipsychotic-induced bone loss: the role of dopamine, serotonin and adrenergic receptor signalling.
Frontiers in cell and developmental biology2023 (year)PMID37305679doi:10.3389/fcell.2023.1184550via CT.gov reference
Glucagon-like peptide-1 attenuates diabetes-associated osteoporosis in ZDF rat, possibly through the RAGE pathway.
BMC musculoskeletal disorders2022 May 17PMID35581617doi:10.1186/s12891-022-05396-5via CT.gov reference
Fracture risk following bariatric surgery: a systematic review and meta-analysis.
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2022 Mar (month)PMID34988627doi:10.1007/s00198-021-06206-9via CT.gov reference
The Influence of Obesity and Metabolic Health on Vascular Health.
Endocrinology and metabolism (Seoul, Korea)2022 Feb (month)PMID35255597doi:10.3803/EnM.2022.101via CT.gov reference
Obesity and Bone: A Complex Relationship.
International journal of molecular sciences2021 Dec 20PMID34948466doi:10.3390/ijms222413662via CT.gov reference
Cross-cultural adaptation and validation of the Greek Version of the SARC-F for evaluating sarcopenia in Greek older adults.
Journal of musculoskeletal & neuronal interactions2020 Dec 1PMID33265078via CT.gov reference
Obesity, osteoporosis and bone metabolism.
Journal of musculoskeletal & neuronal interactions2020 Sep 1PMID32877973via CT.gov reference
Bone in heart failure.
Journal of cachexia, sarcopenia and muscle2020 Apr (month)PMID32087616doi:10.1002/jcsm.12516via CT.gov reference
Bone resorption is unchanged by liraglutide in type 2 diabetes patients: A randomised controlled trial.
Bone2020 Mar (month)PMID31870634doi:10.1016/j.bone.2019.115197via CT.gov reference
Obesity and Bone Health: A Complex Link.
Frontiers in cell and developmental biology2020 (year)PMID33409277doi:10.3389/fcell.2020.600181via CT.gov reference
Effects of Dietary Protein Quantity on Bone Quantity following Weight Loss: A Systematic Review and Meta-analysis.
Advances in nutrition (Bethesda, Md.)2019 Nov 1PMID31301138doi:10.1093/advances/nmz058via CT.gov reference
Liraglutide increases bone formation and inhibits bone resorption in rats with glucocorticoid-induced osteoporosis.
Journal of endocrinological investigation2019 Sep (month)PMID30955181doi:10.1007/s40618-019-01034-5via CT.gov reference
Obesity in the Older Adult: Special Issue.
Journal of nutrition in gerontology and geriatrics2019 Jan-Mar (year)PMID30806583doi:10.1080/21551197.2018.1564197via CT.gov reference
Liraglutide exerts a bone-protective effect in ovariectomized rats with streptozotocin-induced diabetes by inhibiting osteoclastogenesis.
Experimental and therapeutic medicine2018 Jun (month)PMID29805533doi:10.3892/etm.2018.6043via CT.gov reference
Use of CTX-I and PINP as bone turnover markers: National Bone Health Alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability.
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2017 Sep (month)PMID28631236doi:10.1007/s00198-017-4082-4via CT.gov reference
Bone Turnover Markers in the Diagnosis and Monitoring of Metabolic Bone Disease.
Clinical chemistry2017 Feb (month)PMID27940448doi:10.1373/clinchem.2016.259085via CT.gov reference
The Definition and Prevalence of Obesity and Metabolic Syndrome.
Advances in experimental medicine and biology2017 (year)PMID28585193doi:10.1007/978-3-319-48382-5_1via CT.gov reference
Does Diet-Induced Weight Loss Lead to Bone Loss in Overweight or Obese Adults? A Systematic Review and Meta-Analysis of Clinical Trials.
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2015 Dec (month)PMID26012544doi:10.1002/jbmr.2564via CT.gov reference
GLP-1 Receptor Agonist Treatment Increases Bone Formation and Prevents Bone Loss in Weight-Reduced Obese Women.
The Journal of clinical endocrinology and metabolism2015 Aug (month)PMID26043228doi:10.1210/jc.2015-1176via CT.gov reference
Weight loss and bone mineral density.
Current opinion in endocrinology, diabetes, and obesity2014 Oct (month)PMID25105997doi:10.1097/MED.0000000000000087via CT.gov reference
Could biomarkers of bone, cartilage or synovium turnover be used for relapse prediction in rheumatoid arthritis patients?
Mediators of inflammation2014 (year)PMID24744505doi:10.1155/2014/537324via CT.gov reference
Public health impact of osteoporosis.
The journals of gerontology. Series A, Biological sciences and medical sciences2013 Oct (month)PMID23902935doi:10.1093/gerona/glt093via CT.gov reference
Dynamics of bone turnover markers in patients with heart failure and following haemodynamic improvement through ventricular assist device implantation.
European journal of heart failure2012 Dec (month)PMID22989867doi:10.1093/eurjhf/hfs138via CT.gov reference
Validation of a Greek version of PSS-14; a global measure of perceived stress.
Central European journal of public health2012 Jun (month)PMID22966732doi:10.21101/cejph.a3698via CT.gov reference
Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards.
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2011 Feb (month)PMID21184054doi:10.1007/s00198-010-1501-1via CT.gov reference
Validating and norming of the Greek SF-36 Health Survey.
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2005 Jun (month)PMID16047519doi:10.1007/s11136-004-6014-yvia CT.gov reference
Effects of inhaled corticosteroids on bone density and metabolism.
The Journal of allergy and clinical immunology1998 Apr (month)PMID9563372doi:10.1016/s0091-6749(98)70159-9via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.