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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Cambridge Weight Plan Limited | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 3 mg | Experimental | 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. |
|
| Liraglutide 3 mg placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide 3 mg (Saxenda) | Drug |
| ||
| Liraglutide 3 mg placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | One of two co-primary outcomes | Week 0 to 52 |
| KOOS pain subscale | Two of two co-primary outcomes. The Knee injury and Osteoarthritis Outcome Score (KOOS); the pain subscale (9 items) | Week 0 to 52 |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS symptom subscale | Knee injury and Osteoarthritis Outcome Score (KOOS); the symptoms subscale (7 items) | Week 0 to 52 |
| KOOS ADL subscale | Knee injury and Osteoarthritis Outcome Score (KOOS); the Activities of Daily Living (ADL) subscale (17 items) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik R Gudbergsen, MD, PhD | The Parker Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology | Frederiksberg | Capital Region | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39877802 | Derived | Poulsen AS, Stisen ZR, Skougaard M, Christensen R, Overgaard A, Gudbergsen H, Jacobsen S, Balslev-Clausen AP, Henriksen M, Kristensen LE, Bliddal H. 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. Osteoarthr Cartil Open. 2025 Jan 3;7(1):100562. doi: 10.1016/j.ocarto.2024.100562. eCollection 2025 Mar. | |
| 33471039 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Drug |
|
| Week 0 to 52 |
| KOOS sport and recreation subscale | Knee injury and Osteoarthritis Outcome Score (KOOS); the sport and recreation subscale (5 items) | Week 0 to 52 |
| KOOS health related QoL subscale | Knee injury and Osteoarthritis Outcome Score (KOOS); the health related quality of life (QoL) subscale (4 items) | Week 0 to 52 |
| Change in total score in the ICOAP questionnaire | The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 11 items | Week 0 to 52 |
| Change in the constant pain subscale in the ICOAP questionnaire | The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 5 items | Week 0 to 52 |
| Change in the intermittent pain subscale in the ICOAP questionnaire | The Intermittent and Constant Osteoarthritis Pain questionnaire (ICOAP); 6 items | Week 0 to 52 |
| Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale; 5 items | Week 0 to 52 |
| Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale; 2 items | Week 0 to 52 |
| Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale; 17 items | Week 0 to 52 |
| Proportion of participants with ≥5% weight loss | The proportion of patients with or with more than a 5% weight loss 52 weeks after randomization | Week 0 to 52 |
| Proportion of participants with ≥10% weight loss | The proportion of patients with or with more than a 10% weight loss 52 weeks after randomization | Week 0 to 52 |
| Change in BMI | Change in body mass index 52 weeks after randomization | Week 0 to 52 |
| Change in waist circumference | Change in waist circumference 52 weeks after randomization | Week 0 to 52 |
| Change in waist/hip circumference ratio | Change in the ratio waist circumference/hip circumference 52 weeks after randomization | Week 0 to 52 |
| Derived |
| Gudbergsen H, Overgaard A, Henriksen M, Waehrens EE, Bliddal H, Christensen R, Nielsen SM, Boesen M, Knop FK, Astrup A, Rasmussen MU, Bartholdy C, Daugaard CL, Ellegaard K, Heitmann BL, Bartels EM, Danneskiold-Samsoe B, Kristensen LE. Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial. Am J Clin Nutr. 2021 Feb 2;113(2):314-323. doi: 10.1093/ajcn/nqaa328. |
| 32165240 | Derived | Daugaard 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. |
| 31061017 | Derived | Gudbergsen H, Henriksen M, Waehrens 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. |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |