Liraglutide 3 mg for Knee Osteoarthritis

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Gudbergsen
• Collaborators: Cambridge Weight Plan Limited; Novo Nordisk A/S
• Treatments: Liraglutide

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