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Completed

NCT Number: NCT02905864

Liraglutide 3 mg for Knee Osteoarthritis

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Rheumatology

Frederiksberg, Capital Region, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liraglutide 3 mg (Saxenda)

Drug

Liraglutide 3 mg placebo

Drug

Primary outcomes

  1. Change in body weight

    Time frame: Week 0 to 52

    One of two co-primary outcomes

  2. KOOS pain subscale

    Time frame: Week 0 to 52

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

Secondary outcomes

  1. KOOS symptom subscale

    Time frame: Week 0 to 52

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

  2. KOOS ADL subscale

    Time frame: Week 0 to 52

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Change in body mass index 52 weeks after randomization

  14. Change in waist circumference

    Time frame: Week 0 to 52

    Change in waist circumference 52 weeks after randomization

  15. Change in waist/hip circumference ratio

    Time frame: Week 0 to 52

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

Sponsors and collaborators

Lead sponsor

Henrik Gudbergsen

Other

Collaborators

  • Cambridge Weight Plan Limited
  • Novo Nordisk A/S

Registry information

Official study title

Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial

Acronym: LOSEIT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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