Department of Rheumatology
Frederiksberg, Capital Region, 2000, Denmark
NCT Number: NCT02905864
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.
Looking for future studies?
Notify Me18 year–74 year
All sexes
Interventional
Phase 4
Frederiksberg, Capital Region, 2000, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Week 0 to 52
One of two co-primary outcomes
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)
Time frame: Week 0 to 52
Knee injury and Osteoarthritis Outcome Score (KOOS); the symptoms subscale (7 items)
Time frame: Week 0 to 52
Knee injury and Osteoarthritis Outcome Score (KOOS); the Activities of Daily Living (ADL) subscale (17 items)
Time frame: Week 0 to 52
Knee injury and Osteoarthritis Outcome Score (KOOS); the sport and recreation subscale (5 items)
Time frame: Week 0 to 52
Knee injury and Osteoarthritis Outcome Score (KOOS); the health related quality of life (QoL) subscale (4 items)
Time frame: Week 0 to 52
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 11 items
Time frame: Week 0 to 52
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 5 items
Time frame: Week 0 to 52
The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 6 items
Time frame: Week 0 to 52
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale; 5 items
Time frame: Week 0 to 52
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale; 2 items
Time frame: Week 0 to 52
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale; 17 items
Time frame: Week 0 to 52
The proportion of patients with or with more than a 5% weight loss 52 weeks after randomization
Time frame: Week 0 to 52
The proportion of patients with or with more than a 10% weight loss 52 weeks after randomization
Time frame: Week 0 to 52
Change in body mass index 52 weeks after randomization
Time frame: Week 0 to 52
Change in waist circumference 52 weeks after randomization
Time frame: Week 0 to 52
Change in the ratio waist circumference/hip circumference 52 weeks after randomization
Henrik Gudbergsen
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT04730557
Arthritis, Body Weight
Durham, North Carolina, United States
View Trial DetailsNCT00194051
Arthritis, Body Weight
Cleveland, Ohio, United States
View Trial DetailsNCT03937934
Arthritis, Body Weight
Mankato, Minnesota, United States
View Trial DetailsNCT02928679
Arthritis, Body Weight
Frederiksberg, Capital Region, Denmark
View Trial Details