Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Liraglutide 3 mg for Knee Osteoarthritis

Short name LOSEIT

Overview

Status
Completed
Phase
Phase 4
Enrollment
150 participants (estimated)
Sponsor
Henrik Gudbergsen · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Nov 2016
Primary completion
Feb 2019
Completion
Mar 2019
First posted
19 Sept 2016 (estimated)
Last update posted
25 Mar 2019
Conditions
Osteoarthritis · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 4

    LOSEIT

    NCT02905864

    Nov 2016 to Mar 2019

Registry summary

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

A randomised, double blind, placebo-controlled, parallel group, and single-centre trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis. Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a low-calorie diet and dietetic counselling. At week 0 patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

Interventions

  • Liraglutide 3 mg (Saxenda)Drug
  • Liraglutide 3 mg placeboDrug

Arms2

  • Experimental

    Liraglutide 3 mg

    Arm description: Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg QD administered in a 6 mg/mL, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks.

  • Placebo comparator

    Liraglutide 3 mg placebo

    Arm description: Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg placebo QD administered in a 6 mg/mL drug equivalent volumes, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in body weight

    Time frame · Week 0 to 52

    Registry description

    One of two co-primary outcomes

  2. KOOS pain subscale

    Time frame · Week 0 to 52

    Registry description

    Two of two co-primary outcomes. The Knee injury and Osteoarthritis Outcome Score (KOOS); the pain subscale (9 items)

Secondary outcomes(15)
  1. KOOS symptom subscale

    Time frame · Week 0 to 52

    Registry description

    Knee injury and Osteoarthritis Outcome Score (KOOS); the symptoms subscale (7 items)

  2. KOOS ADL subscale

    Time frame · Week 0 to 52

    Registry description

    Knee injury and Osteoarthritis Outcome Score (KOOS); the Activities of Daily Living (ADL) subscale (17 items)

  3. KOOS sport and recreation subscale

    Time frame · Week 0 to 52

    Registry description

    Knee injury and Osteoarthritis Outcome Score (KOOS); the sport and recreation subscale (5 items)

  4. KOOS health related QoL subscale

    Time frame · Week 0 to 52

    Registry description

    Knee injury and Osteoarthritis Outcome Score (KOOS); the health related quality of life (QoL) subscale (4 items)

  5. Change in total score in the ICOAP questionnaire

    Time frame · Week 0 to 52

    Registry description

    The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 11 items

  6. Change in the constant pain subscale in the ICOAP questionnaire

    Time frame · Week 0 to 52

    Registry description

    The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 5 items

  7. Change in the intermittent pain subscale in the ICOAP questionnaire

    Time frame · Week 0 to 52

    Registry description

    The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 6 items

  8. Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale

    Time frame · Week 0 to 52

    Registry description

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale; 5 items

  9. Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale

    Time frame · Week 0 to 52

    Registry description

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale; 2 items

  10. Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale

    Time frame · Week 0 to 52

    Registry description

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale; 17 items

  11. Proportion of participants with ≥5% weight loss

    Time frame · Week 0 to 52

    Registry description

    The proportion of patients with or with more than a 5% weight loss 52 weeks after randomization

  12. Proportion of participants with ≥10% weight loss

    Time frame · Week 0 to 52

    Registry description

    The proportion of patients with or with more than a 10% weight loss 52 weeks after randomization

  13. Change in BMI

    Time frame · Week 0 to 52

    Registry description

    Change in body mass index 52 weeks after randomization

  14. Change in waist circumference

    Time frame · Week 0 to 52

    Registry description

    Change in waist circumference 52 weeks after randomization

  15. Change in waist/hip circumference ratio

    Time frame · Week 0 to 52

    Registry description

    Change in the ratio waist circumference/hip circumference 52 weeks after randomization

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.

Completed trials do not always post results.

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

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2025

1 result

Effect of weight loss and liraglutide on neutrophil gelatinase-associated lipocalin levels among individuals with overweight and knee osteoarthritis: Exploratory analyses of a randomized controlled trial.

Poulsen et al. 2025Osteoarthritis and cartilage opencited by 2

PMID 39877802PMC11773487DOI 10.1016/j.ocarto.2024.100562PUB-39877802

CC BY1 result

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

Corrected

Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial.

Gudbergsen et al. 2021The American journal of clinical nutritioncited by 102

PMID 33471039DOI 10.1093/ajcn/nqaa328PUB-33471039

Full text at the publisher

PubMed tag: none · 2019

Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial.

Gudbergsen et al. 2019BMJ opencited by 8

PMID 31061017PMC6501972DOI 10.1136/bmjopen-2018-024065PUB-31061017

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

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

  • DerivedDaugaard CL, Henriksen M, Riis RGC, Bandak E, Nybing JD, Hangaard S, Bliddal H, Boesen M. The impact of a significant weight loss on inflammation assessed on DCE-MRI and static MRI in knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2020 Jun;28(6):766-773. doi: 10.1016/j.joca.2020.02.837. Epub 2020 Mar 10. PMID 32165240

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 74 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent obtained * Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3) * Age ≥ 18 years and \< 75 years * Body mass index (BMI) ≥ 27 kg/m2 * Stable body weight during the previous 3 months (\< 5 kg self-reported weight change) * Motivated for weight loss Exclusion Criteria: * On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months) * Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial * Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine * Type 1 diabetes * Type 2 diabetes treated with glucose-lowering drugs other than metformin * Alloplasty in target knee joint (see section 6.3) * End stage disease in target knee joint (Kellgren-Lawrence grade 4) * Immuno-inflammatory disease * Chronic wide-spread pain * Pregnancy or insufficient anti-conception therapy for female fertile patients * Breast-feeding * Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 x above upper normal range (UNR) * Surgery scheduled for the trial duration period, except for minor surgical procedures * Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment * Previous surgical treatment for obesity (excluding liposuction \>1 year before trial entry) * Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L * Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain * Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * Inflammatory bowel disease * Congestive heart failure, New York Heart Association (NYHA) class III-IV * Diabetic gastroparesis * History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer * History of cancer with the exception of in-situ malignancies of the skin or cervix uteri * History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder * Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial * Inability to speak Danish fluently * A mental state impeding compliance with the program * Use of opioids or similar strong analgesics * Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema

PepBank is a research reference. Talk to a doctor before you use any peptide.