liraglutide 3 mg for knee osteoarthritis

Conditions: Osteoarthritis; Obesity

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.


Eligibility criteria:
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

Keywords: liraglutide liraglutide 3 mg osteoarthritis obesity