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Trial · Observational

RecruitingPhase not statedRegistry data

Tirzepatide vs Liraglutide in Bone

Short name TiLi-BONE

NCTNCT07094568 (opens ClinicalTrials.gov in a new tab)Other id7130/23-05-25
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase not stated
Enrollment
72 participants (estimated)
Sponsor
National and Kapodistrian University of Athens · Other
Design
Not stated
Countries
1 country

Greece

Start
23 May 2025
Primary completion
30 Dec 2026 (estimated)
Completion
30 Dec 2026 (estimated)
First posted
30 Jul 2025
Last update posted
21 Jan 2026
Conditions
Obesity (Disorder)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph –

    TiLi-BONE

    NCT07094568

    23 May 2025 to est. 30 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms2

  • Other

    Liraglutide

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

  • Other

    Tirzepatide

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in serum CTX concentration

    Time frame · Baseline and 3 months after intervention initiation

    Registry description

    Evaluation of changes in the bone resorption marker CTX at 3 months after intervention initiation in participants treated with tirzepatide versus liraglutide

Secondary outcomes(4)

  1. Change in body weight

    Time frame · Baseline and 6 months after intervention initiation

    Registry description

    Evaluation of changes in body weight at 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide

  2. Change in Body Mass Index (BMI)

    Time frame · Baseline and 6 months after intervention initiation

    Registry description

    Evaluation of changes in BMI at 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide

  3. Change in Bone Mineral Density (BMD)

    Time frame · Baseline and 6 months after intervention initiation

    Registry description

    Evaluation of changes in BMD measured by DXA scan at 6 months after intervention initiation in participants treated with tirzepatide versus liraglutide

  4. Change in Body Composition Parameters

    Time frame · Baseline and 6 months after intervention initiation

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies8

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

4 results

Bone resorption is unchanged by liraglutide in type 2 diabetes patients: A randomised controlled trial.

Hygum et al. 2020Bonecited by 64

PMID 31870634DOI 10.1016/j.bone.2019.115197PUB-31870634

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2015

6 results

GLP-1 Receptor Agonist Treatment Increases Bone Formation and Prevents Bone Loss in Weight-Reduced Obese Women.

Iepsen et al. 2015The Journal of clinical endocrinology and metabolismcited by 153

PMID 26043228DOI 10.1210/jc.2015-1176PUB-26043228

Rights unknown6 results
Source linkSee results (6)

More studies

6 studies on this page

Indexing hint: Review · 2024

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.

Stefanakis et al. 2024Metabolism: clinical and experimentalcited by 98

PMID 39481534DOI 10.1016/j.metabol.2024.156057PUB-39481534

Full text at the publisher
Publisher page

PubMed tag: none · 2024

Effects of Semaglutide and Tirzepatide on Bone Metabolism in Type 2 Diabetic Mice.

Lv et al. 2024Pharmaceuticals (Basel, Switzerland)cited by 15

PMID 39770498PMC11728704DOI 10.3390/ph17121655PUB-39770498

CC BY
Download PDF

Indexing hint: Animal study · 2023

Effect of Liraglutide on Osteoporosis in a Rat Model of Type 2 Diabetes Mellitus: A Histological, Immunohistochemical, and Biochemical Study.

Fathy et al. 2023Microscopy and microanalysis : the official journal of Microscopy Society of America, Microbeam Analysis Society, Microscopical Society of Canadacited by 6

PMID 37832035DOI 10.1093/micmic/ozad102PUB-37832035

Full text at the publisher
Publisher page

PubMed tag: none · 2022

Glucagon-like peptide-1 attenuates diabetes-associated osteoporosis in ZDF rat, possibly through the RAGE pathway.

Cheng et al. 2022BMC musculoskeletal disorderscited by 29

PMID 35581617PMC9112483DOI 10.1186/s12891-022-05396-5PUB-35581617

CC BY
Download PDF

Indexing hint: Animal study · 2019

Liraglutide increases bone formation and inhibits bone resorption in rats with glucocorticoid-induced osteoporosis.

Yang et al. 2019Journal of endocrinological investigationcited by 40

PMID 30955181DOI 10.1007/s40618-019-01034-5PUB-30955181

Full text at the publisher
Publisher page

PubMed tag: none · 2018

Liraglutide exerts a bone-protective effect in ovariectomized rats with streptozotocin-induced diabetes by inhibiting osteoclastogenesis.

Wen et al. 2018Experimental and therapeutic medicinecited by 45

PMID 29805533PMC5958780DOI 10.3892/etm.2018.6043PUB-29805533

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultGreenblatt MB, Tsai JN, Wein MN. Bone Turnover Markers in the Diagnosis and Monitoring of Metabolic Bone Disease. Clin Chem. 2017 Feb;63(2):464-474. doi: 10.1373/clinchem.2016.259085. Epub 2016 Dec 9. PMID 27940448
  • ResultKatsarou A, Panagiotakos D, Zafeiropoulou A, Vryonis M, Skoularigis I, Tryposkiadis F, Papageorgiou C. Validation of a Greek version of PSS-14; a global measure of perceived stress. Cent Eur J Public Health. 2012 Jun;20(2):104-9. doi: 10.21101/cejph.a3698. PMID 22966732
  • ResultPappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. doi: 10.1007/s11136-004-6014-y. PMID 16047519
  • ResultTsekoura M, Billis E, Tsepis E, Lampropoulou S, Beaudart C, Bruyere O, Yilmaz O, Bahat G, Gliatis J. Cross-cultural adaptation and validation of the Greek Version of the SARC-F for evaluating sarcopenia in Greek older adults. J Musculoskelet Neuronal Interact. 2020 Dec 1;20(4):505-512. PMID 33265078
  • ResultDenarie D, Constant E, Thomas T, Marotte H. Could biomarkers of bone, cartilage or synovium turnover be used for relapse prediction in rheumatoid arthritis patients? Mediators Inflamm. 2014;2014:537324. doi: 10.1155/2014/537324. Epub 2014 Mar 12. PMID 24744505
  • ResultFarup PG. Changes in bone turnover markers 6-12 months after bariatric surgery. Sci Rep. 2024 Jun 27;14(1):14844. doi: 10.1038/s41598-024-65952-y. PMID 38937532
  • ResultWu C, Kato TS, Pronschinske K, Qiu S, Naka Y, Takayama H, Schulze-Spate U, Cremers S, Shane E, Mancini D, Schulze PC. Dynamics of bone turnover markers in patients with heart failure and following haemodynamic improvement through ventricular assist device implantation. Eur J Heart Fail. 2012 Dec;14(12):1356-65. doi: 10.1093/eurjhf/hfs138. Epub 2012 Sep 18. PMID 22989867
  • ResultWoodcock A. Effects of inhaled corticosteroids on bone density and metabolism. J Allergy Clin Immunol. 1998 Apr;101(4 Pt 2):S456-9. doi: 10.1016/s0091-6749(98)70159-9. PMID 9563372
  • ResultWeerasinghe DK, Hodge JM, Pasco JA, Samarasinghe RM, Azimi Manavi B, Williams LJ. Antipsychotic-induced bone loss: the role of dopamine, serotonin and adrenergic receptor signalling. Front Cell Dev Biol. 2023 May 25;11:1184550. doi: 10.3389/fcell.2023.1184550. eCollection 2023. PMID 37305679
  • ResultLoncar G, Cvetinovic N, Lainscak M, Isakovic A, von Haehling S. Bone in heart failure. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):381-393. doi: 10.1002/jcsm.12516. Epub 2020 Feb 22. PMID 32087616
  • ResultVasikaran S, Eastell R, Bruyere O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JA; IOF-IFCC Bone Marker Standards Working Group. Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int. 2011 Feb;22(2):391-420. doi: 10.1007/s00198-010-1501-1. Epub 2010 Dec 24. PMID 21184054
  • ResultSchini M, Vilaca T, Gossiel F, Salam S, Eastell R. Bone Turnover Markers: Basic Biology to Clinical Applications. Endocr Rev. 2023 May 8;44(3):417-473. doi: 10.1210/endrev/bnac031. PMID 36510335
  • ResultFilella X, Guanabens N. Clinical use of bone markers: a challenge to variability. Adv Lab Med. 2023 Aug 28;5(1):7-14. doi: 10.1515/almed-2023-0092. eCollection 2024 Mar. PMID 38634081

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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