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Liraglutide 3 mg for Knee Osteoarthritis (LOSEIT)

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ClinicalTrials.gov Identifier: NCT02905864
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
Novo Nordisk A/S
Cambridge Weight Plan Limited
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date March 25, 2019
Study Start Date  ICMJE November 2016
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • Change in body weight [ Time Frame: Week 0 to 52 ]
    One of two co-primary outcomes
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02905864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • KOOS symptom subscale [ Time Frame: Week 0 to 52 ]
    Knee injury and Osteoarthritis Outcome Score (KOOS); the symptoms subscale (7 items)
  • 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)
  • 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)
  • 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)
  • Change in total score in the ICOAP questionnaire [ Time Frame: Week 0 to 52 ]
    The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 11 items
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Change in BMI [ Time Frame: Week 0 to 52 ]
    Change in body mass index 52 weeks after randomization
  • Change in waist circumference [ Time Frame: Week 0 to 52 ]
    Change in waist circumference 52 weeks after randomization
  • Change in waist/hip circumference ratio [ Time Frame: Week 0 to 52 ]
    Change in the ratio waist circumference/hip circumference 52 weeks after randomization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liraglutide 3 mg for Knee Osteoarthritis
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Obesity
Intervention  ICMJE
  • Drug: Liraglutide 3 mg (Saxenda)
  • Drug: Liraglutide 3 mg placebo
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Liraglutide 3 mg (Saxenda)
  • 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.

    Intervention: Drug: Liraglutide 3 mg placebo
Publications * Gudbergsen H, Henriksen M, Wæhrens EE, Overgaard A, Bliddal H, Christensen R, Boesen MP, Knop FKK, Astrup A, Rasmussen MU, Bartholdy C, Daugaard C, Bartels EM, Ellegaard K, Heitmann BL, Kristensen LE. 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. BMJ Open. 2019 May 5;9(5):e024065. doi: 10.1136/bmjopen-2018-024065.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 16, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905864
Other Study ID Numbers  ICMJE 137.00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Henrik Gudbergsen, Parker Research Institute
Study Sponsor  ICMJE Henrik Gudbergsen
Collaborators  ICMJE
  • Novo Nordisk A/S
  • Cambridge Weight Plan Limited
Investigators  ICMJE
Principal Investigator: Henrik R Gudbergsen, MD, PhD The Parker Institute
PRS Account Parker Research Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP