iraglutide for obese patients with knee osteoarthritis
- Conditions
- Adult (= 18 years of age) overweight or obese patients (BMI = 27 kg/m2 ) above 18 years of age with knee osteoarthritis (OA) defined by clinical diagnosis of knee OA according to the 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)MedDRA version: 19.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859MedDRA version: 19.0Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-005163-16-DK
- Lead Sponsor
- The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
•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
•Use of opioids or similar strong analgesics
•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)
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method